Atlas FDA

MONOJECT SAFETY NEEDLE

FDA 510(k) clearance K012736 · decided 2001-10-25

Clearance details

K-number
K012736
Device name
MONOJECT SAFETY NEEDLE
Applicant
Tyco Healthcare
Decision
Substantially Equivalent
Date received
2001-08-16
Decision date
2001-10-25
Days to decision
70 days
Clearance type
Traditional
Product code
FMI
Device class
2
Regulation number
880.5570
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Mansfield, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T) (K260933)Hangzhou Qiantang Longyue Biotechnology Co., Ltd.2026-08-07
Profoject™ Dual-Safety Pen Needles (K261829)CMT Health PTE., Ltd.2026-07-29
Profoject™ Pen Needles (Model A; Model B) (K260739)CMT Health PTE., Ltd.2026-07-15
Profoject™ Safety Pen Needles (K260855)CMT Health PTE., Ltd.2026-06-10
Verisafe Safety Sterile Needles (SSN) (K254273)Promisemed Hangzhou Meditech Co., Ltd.2026-04-16
Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle (K252908)Sandstone Medical (Suzhou), Inc.2026-03-25
PRESSONE™ (K253047)Nipro Medical Corporation2026-03-24
Safety Pen Needle (K253622)Ningbo Medsun Medical Co., Ltd.2026-03-18
Pen Needle (K252886)Hh Global Technology, Inc.2026-01-06
Pen Injector Needle 32.5 (K250700)Terumo Corporation2025-11-21
Profoject™ Disposable Needle (K252631)CMT Health PTE., Ltd.2025-10-16
Intraosseous Infusion Needles (K250724)Spectrum Vascular2025-07-30

Recalls involving this device

RecordFirmDate
Centurion Healthcare Products Laceration Tray, sterile; (Reorder SUT8805A) Tri-State Hospi recall (Z-0729-2008)Tri-State Hospital Supply Corporation2008-02-23
Centurion Healthcare Products Laceration Tray, sterile; (Reorder SUT8805A) Tri-State Hospi recall (Z-0730-2008)Tri-State Hospital Supply Corporation2008-02-23
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 20G X 1 inch Product Code: 888183 recall (Z-0064-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 20G X 1.5 inch Product Number: 88 recall (Z-0065-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 21G X 1 inch Product Number: 8881 recall (Z-0066-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 22G X 1 inch Product Number: 8881 recall (Z-0067-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 22G X 1.5 inch Product Number: 88 recall (Z-0068-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 23G X 1 inch Product Number: 8881 recall (Z-0069-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 25G X 5/8 inch Product Number: 88 recall (Z-0070-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 18G X 1 inch Product Number: 8881 recall (Z-0071-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 20G X 1 inch Product Number: 8881850010 recall (Z-0072-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 20G X 1 inch Product Number: 8881850015 recall (Z-0073-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 21G X 1 inch Product Number: 8881850110 recall (Z-0074-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 21G X 1 inch Product Number: 8881850115 recall (Z-0075-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 22G X 1 inch Product Number: 8881850210 recall (Z-0076-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 22G X 1 inch Product Number: 8881850215 recall (Z-0077-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 23G X 1 inch Product Number: 8881850310 recall (Z-0078-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 23G X 5/8 inch Product Number: 8881850358 recall (Z-0079-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 25G X 1 inch Product Number: 8881850510 recall (Z-0080-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 25G X 5/8 inch Product Number: 8881850558 recall (Z-0081-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 18G X 1 inch Product Number: 8881850810 recall (Z-0082-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 19G X 1 inch Product Number: 8881850910 recall (Z-0084-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 19G X 1 inch Product Number: 8881850915 recall (Z-0085-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 20G X 1.5 inch Product Number: 8 recall (Z-0086-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 21G X 1 inch Product Number: 888 recall (Z-0087-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 21G X 1.5 inch Product Number: 8 recall (Z-0088-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 18G X 1 inch Product Number: 888 recall (Z-0089-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 6cc Syringe with Safety Needle 20G X 1.5 inch Product Number: 88 recall (Z-0090-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 6cc Syringe with Safety Needle 21G X 1 inch Product Number: 8881 recall (Z-0091-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 6cc Syringe with Safety Needle 21G X 1.5 inch Product Number: 88 recall (Z-0092-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 6cc Syringe with Safety Needle 18G X 1 inch Product Number: 8881 recall (Z-0093-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 20G X 1 inch Product Number: 5551 recall (Z-0094-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 20G X 1.5 inch Product Number: 55 recall (Z-0095-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 21G X 1 inch Product Number: 5551 recall (Z-0096-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 21G X 1.5 inch Product Number: 55 recall (Z-0097-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 22G X 1 inch Product Number: 5551 recall (Z-0098-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 22G X 1.5 inch Product Number: 55 recall (Z-0099-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 23G X 1 inch Product Number: 5551 recall (Z-0100-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 25G X 1 inch Product Number: 5551 recall (Z-0101-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 3cc Syringe with Safety Needle 25G X 5/8 inch Product Number: 55 recall (Z-0102-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 21G X 1 inch Product Number: 5551850110 recall (Z-0103-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 21G X 1 inch Product Number: 5551850115 recall (Z-0104-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 23G X 1 inch Product Number: 5551850310 recall (Z-0105-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 25G X 5/8 inch Product Number: 5551850558 recall (Z-0106-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN SAFETY NEEDLE 19G X 1 inch Product Number: 5551850915 recall (Z-0107-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 20G X 1.5 inch Product Number: 5 recall (Z-0108-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 21G X 1 inch Product Number: 555 recall (Z-0109-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 21G X 1.5 inch Product Number: 5 recall (Z-0110-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 22G X 1.5 inch Product Number: 5 recall (Z-0111-05)Kendall Healthcare Products Co2004-11-02
Kendall MONOJECT MAGELLAN 12cc Syringe with Safety Needle 18G X 1 inch Product Number: 555 recall (Z-0112-05)Kendall Healthcare Products Co2004-11-02