Atlas FDA

LRO

110 FDA 510(k) clearances · Product code

79 daysmedian time to decision
302 days90th percentile
110clearances measured

FDA profile

Official device name
General Surgery Tray
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4370
Medical specialty
General, Plastic Surgery
FDA definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
Adverse events (MAUDE)
2021: 920 · 2022: 1,134 · 2023: 1,913 · 2024: 3,031 · 2025: 5,555 · 2026: 4,107
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

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
BASIC BIOPSY TRAY. DISPOSABLE, STERILE (K964921)Trinity Laboratories, Inc.1997-01-22
DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY (K963715)Grand Medical Products1996-11-27
SKIN SCRUB TRAY (K963721)Grand Medical Products1996-11-27
SUCTION CATHETER TRAY PRODUCT NO. 900277 (K964011)Customed, Inc.1996-11-25
PROD. NO. 02-031 - LACERATION TRAY (K963443)Continental Medical Laboratories, Inc.1996-10-17
MEDLINE RADIOLOGY-DIAGNOSTIC KITS (K962826)Medline Industries, Inc.1996-09-16
PARACENTESIS TRAYS (K961863)Tri-Med, Inc.1996-05-28
HOSPITAL LAUNDRY SERVICES SURGICAL PACKS (K953083)Hospital Laundry Services1996-05-14
JJ SKINNER CAREKITS MINOR SURGICAL PROCEDURE TRAY (K961683)J.J. Skinner, Inc.1996-05-10
RADIOLOGY PACKS (K952539)Sterile Concepts, Inc.1995-07-14
GENERAL AND PLASTIC SURGERY PACKS (K951478)Sterile Concepts, Inc.1995-06-13
WOUND CLOSURE/LACERATION TRAY (K950295)Customed, Inc.1995-04-18
SINGLE USE INSTRUMENT TRAY (K951149)Medcare Custom Packaging, Inc.1995-04-06
NEEDLE/CANNULA (K950574)Tri-Med Specialties, Inc.1995-02-24
DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT (K945831)Micromed Development Corp.1995-01-20
SHAVE PREP KIT (K945481)Harding Industries, Inc.1994-12-23
PARACENTESIS NEEDLES/CANNULAS (K945160)Tri-Med Specialties, Inc.1994-11-14
CHIBA STYLE BIOPSY NEEDLE (K944044)Kormed, Inc.1994-10-03
BONE MARROW BIOPSY TRAY (K941846)Kormed, Inc.1994-05-18
JJ SKINNER CAREKITS(TM) DRY/WET/GEL SKIN SCRUB KIT (K925467)J.J. Skinner, Inc.1994-05-11
STERILE DESIGN (K934688)Sterile Design, Inc.1994-03-16
INSTRUMENT TRAY (K935743)Cush Medical Products1994-03-03
CENTRAL LINE TRAY (K936117)Cush Medical Products1994-03-01
DRESSING CHANGE TRAY (K935686)Cush Medical Products1994-02-25
ACU-SUTURE KIT (K933137)Acuderm, Inc.1994-02-22
MILL-ROSE PERCUTANEOUS PROCEDURAL KIT (K935858)Mill-Rose Laboratory1994-02-22
IRRIGATION TRAY (K935740)Cush Medical Products1994-02-22
PATIENT PREOPERATIVE PREP TRAY, SINGLE USE (K930270)Professional Medical Products, Inc.1994-02-17
STERILE DRESSING CHANGE TRAY (K934028)Surgipro, Inc.1994-02-17
O.R. BASIN SET TRAY (K935741)Cush Medical Products1994-02-15
E-Z PREP(R) TRAY WITH HIBICLENS(R) (K935483)Bd Becton Dickinson Vacutainer Systems Preanalytic1994-02-09
CARAPACE STILLWATER BOWL SET (K931820)Carapace, Inc.1994-02-07
CARAPACE PACKING GAUZE TRAYS (K931760)Carapace, Inc.1994-02-04
STERILE LACERATION & DEBRIDEMENT TRAYS (K934029)Surgipro, Inc.1994-02-04
CARAPACE WOUND DRESSING KITS & LACERATION TRAYS (K931758)Carapace, Inc.1994-01-26
VARIOUS KITS AND TRAYS (K920292)Professional Medical Products, Inc.1994-01-26
STERILE TRACHEOSTOMY TRAY (K934030)Surgipro, Inc.1994-01-26
CARAPACE STERILE GAUZE TRAYS (K931759)Carapace, Inc.1994-01-25
CUSTOM PROCEDURE MEDICAL TRAY OR KIT (K931844)Custom Medical Products, Ltd.1994-01-25
CARAPACE CATARACT TRAYS (K931673)Carapace, Inc.1993-12-30
ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCEDURE TRAY (K934428)Sherwood Medical Co.1993-12-30
CARAPACE INSTRUMLENT AND INSTRUMENT SETS (K931824)Carapace, Inc.1993-12-06
TRI-MED PARACENTESIS TRAY (K932652)Tri-Med Specialties, Inc.1993-11-24
MAJOR, MINOR, BASIN TRAYS (PACKS) (K932217)Associated Medical Products Co.1993-11-15
LAP CHOLY TRAYS (PACKS) (K932220)Associated Medical Products Co.1993-09-27
PROCEDURE KIT (K926269)General Medical Co.1993-08-27
MEDLINES REPEAT PERFORMANCE SURGICAL PACK SYSTEM (K930700)Medline Industries, Inc.1993-07-09
STERILE INSTRUMENT TRAYS/BASIN SETS (K924468)Baxter Healthcare Corp1993-07-09
SHAVE PREP TRAYS (NON-STERILE) (K925214)American Healthcare Supply Co., Inc.1993-07-02
STERILE SKIN SCRUB TRAYS (K925216)American Healthcare Supply Co., Inc.1993-06-22
MEDSURG O.R. PROCEDURE TRAY (K914037)Medsurg Industries, Inc.1993-06-22
HOSPITAL KIT SV 105 (K922133)Savoy Medical Supply Co., Inc.1993-06-07
PREP SHAVE KIT (NON-STERILE) (K925016)Customed, Inc.1993-04-26
DYONICS ARTHROSCOPIC KIT (K920267)Smith & Nephew Dyonics, Inc.1993-03-23
ENDO OPTIKS VALUE PACK (K923600)Endo Optics, Inc.1993-03-23
ACE CUSTOM SURGICAL PACK (K922648)Ace Surgical Supply Co., Inc.1993-03-20
MEDSURG LAPAROSCOPY TRAY (K914036)Medsurg Industries, Inc.1992-03-18
STERILE DISPOSABLE WET SKIN SCRUB TRAY (K914174)Medical Device Inspection Co., Inc.1992-02-24
HEART PACK II (K914935)Westmark Hospital Supplies1992-01-31
LASER ENDOSCOPE DISC DECOMPRESSION KITS (K913136)Medical Laser, Inc.1991-11-01
SURGICAL PROCEDURE TRAY/LAPAROSCOPY CHOLECYSTECTOM (K905459)Angiosystems, Inc.1991-04-05
WOUND CLOSURE KIT (K910365)Megadyne Medical Products, Inc.1991-03-28
MEGA LACERATION KIT (K910368)Megadyne Medical Products, Inc.1991-03-18
BIO-GUARD O.R. SCRUB PREP TRAY (K905004)Network Medical Systems, Inc.1991-02-21
CUSTOMED ARTHROSCOPY PACK (K902887)Customed, Inc.1990-09-10
CUSTOMED ORTHOPEDIC II (K902888)Customed, Inc.1990-09-10
CUSTOMED HIP PACT (K903336)Customed, Inc.1990-08-29
CUSTOM WOUND MANAGEMENT KITS AND TRAYS (K901856)Medcare Custom Packaging, Inc.1990-08-01
ANGIOGRAPHY DRAPE PACK (K902293)Biocor Medical, Inc.1990-07-19
SYRINGE INJECTION GUN DELIVERY KITS (K890658)Gastrotech, Inc.1989-10-03
1420 HEEL-STICK(TM) NEONATAL BLOOD SAMPLING KIT (K895202)Transidyne General Corp.1989-09-15
DAVIS+GECK VISADUCT KIT (K894685)Davis & Geck, Inc.1989-08-22
SURGICAL INSTRUMENT KIT, DISPOSABLE (K893814)Bioseal1989-08-10
BIOPSY KIT (K892389)I M, Inc.1989-07-17
SKIN SCRUB KIT (K890570)Kit Pak, Inc.1989-05-05
SUTURE REMOVAL KIT (K890729)Cypress Medical Products, Ltd.1989-04-17
TRACHEOSTOMY CARE AND CLEANING KITS (K890726)Cypress Medical Products, Ltd.1989-03-10
HOMER MAMMALOK LOCALIZATION SHIELD (K885090)North American Instrument Corp.1989-02-14
KLEEN TEST O.R. KIT (K890098)Kleen Test Products1989-01-24
STERILE DISPOSABLE SURGICAL PACKS (K884093)Bolden Surgical Products1988-10-19
STERI-CLENS WOUND CARE KIT (K883250)Absorbent Cotton Co., Inc.1988-08-26
REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR/DRAPE/BAS. (K882684)Standard Textile Co., Inc.1988-08-03
ALCON SURGICAL PROCEDURE PACKS (K880961)Alcon Laboratories1988-04-29
GENERAL PURPOSE KIT (K881083)Med-Dex Intl.1988-04-07
REPAK SURGICAL PACK (GOWN,TOWEL,MAJOR,DRAPE,BASIC) (K880942)Repack Surgical Enterprises, Inc.1988-03-21
CK 4900 SERIES, GOWN AND TOWEL PAK (K874760)Currie Medical Specialties, Inc.1987-12-10
SOFT TISSUE ANCHORING SET KIT (K874439)Concept, Inc.1987-11-20
LAKE WOUND CARE/TREATMENT KIT (K873973)Lake Medical Products, Inc.1987-11-20
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