Atlas FDA

Medline General Surgery Tray

FDA 510(k) clearance K213481 · decided 2022-05-24

Clearance details

K-number
K213481
Device name
Medline General Surgery Tray
Applicant
Medline Industries, Inc.
Decision
Substantially Equivalent
Date received
2021-10-29
Decision date
2022-05-24
Days to decision
207 days
Clearance type
Traditional
Product code
LRO
Device class
2
Regulation number
878.4370
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Northfiled, IL, US
Third-party review
No
Expedited review
No

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RecordFirmDate
Medline Cardiovascular Procedure Kit (K212258)Medline Industries, Inc.2021-12-03
SURGICAL DRAPE KIT - D.I.R.R.A. SRL (K041080)D.I.R.R.A. S.R.L.2004-11-30
QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLE (K030721)Ballard Medical Products2003-03-31
AMSINO TRACHEOSTOMY CARE TRAY (K023276)Amsino International, Inc.2002-12-09
WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY (K980137)Worldwide Medical Technologies, LLC1998-01-30
OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY (K971061)Opportunity, Inc.1997-06-11
OPPORTUNITY INC. GENERAL PURPOSE TRAY (K971062)Opportunity, Inc.1997-06-09
NEUROLOGICAL OR CRANI TRAYS (PACKS) (K932221)Associated Medical Products Co.1997-03-19
PRESBYTERIAN LINEN SERVICES SURGICAL PACKS (K970286)Medline Industries, Inc.1997-03-10
O.R. SCRUB PREP TRAY, STERILE, DISPOSABLE (K965201)Trinity Laboratories, Inc.1997-02-14
RUNYON LARGE VOLUME PARACENTESIS KIT (K970187)Gi Supply1997-02-14
BASIC BIOPSY TRAY. DISPOSABLE, STERILE (K964921)Trinity Laboratories, Inc.1997-01-22

Recalls involving this device

RecordFirmDate
MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS98455 recall (Z-2764-2026)Medline Industries, LP2026-07-23
MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G recall (Z-2747-2026)Medline Industries, LP2026-07-22
MEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2) C-SECTION, M recall (Z-2748-2026)Medline Industries, LP2026-07-22
MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2) TOT recall (Z-2749-2026)Medline Industries, LP2026-07-22
Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267 recall (Z-2736-2026)Medline Industries, LP2026-07-15
Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN HEART recall (Z-2697-2026)Medline Industries, LP2026-07-08
Medline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO CATH recall (Z-2541-2026)Medline Industries, LP2026-06-29
Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART DYNJ909090B OP recall (Z-2611-2026)Medline Industries, LP2026-06-26
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT F recall (Z-2590-2026)Medline Industries, LP2026-06-25
MEDLINE Medical Procedure Kits labeled as BIOBURDEN TEST KIT, Kit Uro Robot Cystectomy, et recall (Z-2497-2026)Medline Industries, LP2026-06-17
Medline convenience kits: 20CM CVC INSERTION KIT ECVC6805B 2L 8.5FR 16CM CVC INSERTION KIT recall (Z-2439-2026)Medline Industries, LP2026-06-12
Medline convenience kits: DRIVELINE MANAGEMENT KIT EBSI1688 PORT DRESSING CHANGE KIT EBSI1 recall (Z-2440-2026)Medline Industries, LP2026-06-12
Medline convenience kits: ACL PACK DYNJ64161C ARTHROSCOPY PACK DYNJ47103D DYNJ67197G DYNJ8 recall (Z-2441-2026)Medline Industries, LP2026-06-12
Medline kits containing Huons Co. Bupivacaine HCL in Dextrose Injection, USP, labeled as: recall (Z-2236-2026)Medline Industries, LP2026-05-28
See RES for complete list. Medline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model N recall (Z-2101-2026)Medline Industries, LP2026-05-07
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, recall (Z-2041-2026)Medline Industries, LP2026-04-30
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ADD recall (Z-1890-2026)Medline Industries, LP2026-04-17
CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F recall (Z-1824-2026)Medline Industries, LP2026-04-16
Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCH recall (Z-1710-2026)Medline Industries, LP2026-04-01
Medline kits containing Tego Connectors Medline APHERESIS SUBQPORT ACCESS KIT SKU DYNDA270 recall (Z-1466-2026)Medline Industries, LP2026-02-24
1) UNIVERSAL KIT, Kit SKU DT22010B; 2) VAD ACCESS KIT, Kit SKU DT22790C; 3) VAD ACCESS KIT recall (Z-1330-2026)Medline Industries, LP2026-02-09
Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F S recall (Z-0448-2026)Medline Industries, LP2025-11-13
Medline Adult Anesthesia Set, REF DYNJ39985G recall (Z-0137-2026)Medline Industries, LP2025-10-10
Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ0382730O; 2) LB BAS recall (Z-2592-2025)Medline Industries, LP2025-09-26
The Medline General Surgery Tray is customized to meet requirements of the hospitals and h recall (Z-2452-2025)MEDLINE INDUSTRIES, LP - Northfield2025-08-27
Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ3 recall (Z-1809-2025)MEDLINE INDUSTRIES, LP - Northfield2025-05-31
Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C recall (Z-1810-2025)MEDLINE INDUSTRIES, LP - Northfield2025-05-31
Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; recall (Z-1505-2025)MEDLINE INDUSTRIES, LP - Northfield2025-04-10
Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTA recall (Z-1368-2025)MEDLINE INDUSTRIES, LP - Northfield2025-03-14
Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER 2, Model Numb recall (Z-1183-2025)MEDLINE INDUSTRIES, LP - Northfield2025-02-19
Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B; 2 recall (Z-0991-2025)MEDLINE INDUSTRIES, LP - Northfield2025-01-29
MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Ca recall (Z-1049-2025)MEDLINE INDUSTRIES, LP - Northfield2025-01-29
Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2) VANTEX 7 recall (Z-1040-2025)MEDLINE INDUSTRIES, LP - Northfield2025-01-28
See DocMan recall (Z-0788-2025)MEDLINE INDUSTRIES, LP - Northfield2024-12-30
MEDLINE HEART CABG CDS, REF CDS983376R recall (Z-0119-2025)MEDLINE INDUSTRIES, LP - Northfield2024-10-17
Centurion procedure kits, labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number AR recall (Z-2767-2024)MEDLINE INDUSTRIES, LP - Northfield2024-08-28
Centurion procedure packs, containing Caina syringes, labeled as: 1) ARTHROGRAPH TRAY, Pac recall (Z-2775-2024)MEDLINE INDUSTRIES, LP - Northfield2024-08-28
Medline procedure packs containing Shenli syringes, labeled as follows: 1) CVC DOUBLE LUME recall (Z-2631-2024)MEDLINE INDUSTRIES, LP - Northfield2024-08-27
Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A recall (Z-2515-2024)MEDLINE INDUSTRIES, LP - Northfield2024-08-07