Atlas FDA

LIFESHIELD BLUNT CANNULA

FDA 510(k) clearance K963351 · decided 1997-02-26

Clearance details

K-number
K963351
Device name
LIFESHIELD BLUNT CANNULA
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1996-08-26
Decision date
1997-02-26
Days to decision
184 days
Clearance type
Traditional
Product code
FMI
Device class
2
Regulation number
880.5570
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Abbott Laboratories

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

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

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30