Atlas FDA

MEDLINE RADIOLOGY-DIAGNOSTIC KITS

FDA 510(k) clearance K962826 · decided 1996-09-16

Clearance details

K-number
K962826
Device name
MEDLINE RADIOLOGY-DIAGNOSTIC KITS
Applicant
Medline Industries, Inc.
Decision
Substantially Equivalent
Date received
1996-07-19
Decision date
1996-09-16
Days to decision
59 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
Mundelein, IL, 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
Medline General Surgery Tray (K213481)Medline Industries, Inc.2022-05-24
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

Recalls involving this device

RecordFirmDate
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 procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD recall (Z-1444-2025)MEDLINE INDUSTRIES, LP - Northfield2025-03-25
Medline Convenience kits labeled as: 1) MINOR BASIC PACK-LF, Pack Number DYNJ0281516M; 2) recall (Z-3025-2024)MEDLINE INDUSTRIES, LP - Northfield2024-09-06