Atlas FDA

FSM

76 FDA 510(k) clearances · Product code

42 daysmedian time to decision
109 days90th percentile
76clearances measured

FDA profile

Official device name
Tray, Surgical, Instrument
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 153 · 2022: 200 · 2023: 168 · 2024: 288 · 2025: 274 · 2026: 261
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
INSTRUMENT TRAY LINER (K971217)General Hospital Supply Corp.1997-05-06
SINGLE USE INSTRUMENT TRAY (K962328)Medcare Medical Group, Inc.1996-08-09
SURGICAL INSTRUMENT TRAY (K944025)Riley Medical, Inc.1994-11-22
ARTHROSCOPY TRAY (K912106)Medical Device Inspection Co., Inc.1991-08-29
OPEN HEART TRAY (K912053)Medical Device Inspection Co., Inc.1991-08-26
HEART CATH TRAY (K912052)Medical Device Inspection Co., Inc.1991-08-20
MAJOR BASIN TRAY (K912104)Medical Device Inspection Co., Inc.1991-08-09
SPLINTER TWEEZERS (K910570)Solan Scissors Sales1991-05-31
REDDICK TROCAR AND CANNULA (K911601)Ideal Medical, Inc.1991-05-21
KEY COMFORT GRIPS (K910328)Key Surgical, Inc.1991-03-06
RICHARD-ALLAN CLAMP COVERS (K905682)Richard-Allan Medical1991-02-19
HAND SURGERY AND IRRIGATION TRAY (MODEL 3625) (K900376)Pmt Corp.1990-04-10
CUSTOM TRAYS, KITS (K894610)L H M Ent., Inc.1990-03-15
STERILE LACERATION TRAY CAT. #749 (K900479)Busse Hospital Disposables, Inc.1990-02-13
THE NEEDLE COUNT AND SHARPS DISPOSAL SYSTEM (K895527)Quantitative Technologies, Inc.1989-10-06
CASF STERILIZATION TRAY (K883193)Terray Manufacturing, Inc.1988-08-10
CASF STERILIZATION TRAY (K883125)Terray Manufacturing, Inc.1988-08-10
BREVET CASSETTE STERILIZATION MODULE (K882617)Brevet, Inc.1988-07-28
STERILIZATION TRAY, TMJ INSTRUMENT SET (K871924)Arthropedics, Inc.1987-06-01
SURGICAL PACKS, SURGICAL KITS AND SURGICAL TRAYS (K871478)Procedure Pak, Inc.1987-05-07
MEDSURG PERCUTANEOUS ASPIRATION BIOPSY (PAB) TRAY (K870892)Medsurg Industries, Inc.1987-04-10
RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY (K870417)North Coast Medi-Tek1987-03-05
SCANLAN (TM) INSTRUMENT TRAY (K864920)Scanlan Intl., Inc.1987-01-12
INSTRUMENT STERILIZATION TRAY (K863726)Medical Technology Development Corp.1986-10-14
SURGICAL LASER ACCESSORIES (SLA) CASE (K862629)Simpson/Basye, Inc.1986-07-17
VENESECTION EQUIPMENT STORAGE TRAY (K862154)Rmp Co.1986-06-16
SURGICAL PACKS, KITS AND TRAYS (K861530)Medical Concepts Development, Inc.1986-05-30
DISPOSABLE SURG KITS/GOWNS/GUARDS/COVERS/MASKS (K861525)D & D Products, Inc.1986-05-06
OPERATING ROOM TRAY (K860160)Medical Design Concepts, Inc.1986-02-27
SURGICAL INSTRUMENT TRAY (K854746)Zbi, Inc.1985-12-17
GENERAL PURPOSE INSTRUMENT TRAYS SUTURE REMOVAL TR (K844613)Packaging Technologies, Inc.1985-01-10
C.A.S.E. CONTAINER (K844652)General Medical Co.1984-12-12
VENESECTION TRAY, ADULT 6050 (K843627)Pro-Lab, Inc.1984-12-04
FLASH GUARD PLASTIC VERSION (K844286)Sparco, Inc.1984-11-19
HU-FRIEDY IMS CASSETTE SYSTEM (K844002)Hu-Friedy Mfg. Co., Inc.1984-11-08
MSI SURGI-GRADE SUTURE TRAY (K843564)Medical Sterilization, Inc.1984-10-31
MSI SURGI-GRADE UNIVERSAL TRACH TRAY (K843561)Medical Sterilization, Inc.1984-10-24
MSI SURGI-GRADE INCISION & DRAIN TRAY (K843563)Medical Sterilization, Inc.1984-10-23
STERILE INSTRUMENT TRAYS-VARIOUS (K843723)E.M. Adams1984-10-23
ABDOMINAL PARACENTESIS TRAY (K842009)Jayco Pharmaceuticals1984-10-23
VARIOUS DISPOSABLE KITS/TRAYS/INSTRU (K840976)Carapace, Inc.1984-05-31
TRACHEOSTOMY CARE TRAY (K841122)Medcare Products1984-04-25
OPERATING ROOM TRAY SET (K840021)Medi-Plast Intl., Inc.1984-03-15
GEN. PURPOSE INSTRUMENT TRAYS & (K833058)Inter-Med Corp.1984-01-31
CONVERTORS FLASH STERILIZING TRAY (K832137)American Convertors Div., American Pharmaseal1983-08-12
VARIOUS INSTRUMENTS & INSTRUMENT TRAYS (K830219)Ascep, Inc.1983-04-12
MEDCARE SUTURE REMOVAL TRAYS (K823854)Medcare Products1983-03-31
MEDCARE GENERAL PURPOSE TRAY (K823856)Medcare Products1983-01-14
HANDI-TRAY (K823438)Treace Medical, Inc.1983-01-14
MEDCARE WOUND CLOSURE TRAY (K823853)Medcare Products1983-01-14
MEDCARE INCISION & DRAINAGE TRAY (K823855)Medcare Products1983-01-14
INSTRA-SAFE (K823430)Instranetics, Inc.1983-01-07
NEEDLE & BLADE COUNTER (K820332)Abco Dist.1982-02-23
INCISION & DRAINAGE TRAY (K812134)E.M. Adams1982-01-15
WOUND CLOSURE INSTRUMENT TRAY (K812133)E.M. Adams1982-01-08
OPERATING ROOM KIT (K811916)American Hospital Supply Corp.1981-10-14
MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL (K811087)Cunningham Woodland, Inc.1981-05-01
STERILE DISPOSABLE INSTRUMENT TRAYS (K810004)Ascep, Inc.1981-01-26
AMPCO-DRESSING CHANGE TRAY-MAJOR DC 7418 (K802965)Associated Medical Products Co.1981-01-05
AMPCO-DRESSING CHANGE TRAY-MAJOR DC (K802964)Associated Medical Products Co.1981-01-05
AUXILIARY TRAY (K802088)American Pharmaseal Div. Ahsc1980-11-28
A.M.P.C.O. SKIN SCRUB TRAY (K802570)Associated Medical Products Co.1980-11-14
CUSTOM LYMPHANGIOGRAM ACCES. PACK-STERI (K801964)American Pharmaseal Div. Ahsc1980-10-10
CUSTOM UNIVERSAL CUTDOWN PREP TRAY (K801965)American Pharmaseal Div. Ahsc1980-10-10
MICRO CLIP STERILIZING CASE #65199 (K801470)Edward Weck, Inc.1980-07-14
ADT DISPOSABLE THIN NEEDLE ASPIRATION (K800418)A.D.T. Lab Industries1980-04-28
MICRESURGICAL TRAY, SM.,MED., & LG. (K800367)Edward Weck, Inc.1980-03-10
CENTRAL VENOUS CATHETER DRESSING TRAY (K791887)Ascep, Inc.1979-10-17
SUTURE REMOVAL TRAY, REORDER 7950&7951 (K791889)Ascep, Inc.1979-10-17
WECK RACK (STERILIZING ACCESSORY TRAY) (K791743)Edward Weck, Inc.1979-09-26
VARIOUS SURG. & DIAGNOSTIC INSTRU. ETC. (K770428)Holco Instrument Corp.1979-09-12
INSTRUMENT TRAY (K772266)Med Fusion Systems, Inc.1978-01-20
ARMOR-KOT SURGICAL INSTRUMENTS (K771680)Storz Instrument Co.1977-11-28
INSTRUMENT RACK FOR DAWSON-YUHL INSTR. (K760579)V. Mueller O.V. Baxter Healthcare Corp.1976-11-02
SUTURE RACK & NEEDLE COUNTER (K760428)Kleen Test Products1976-11-02
INSTRUMENTS, GENERAL HAND & SURGERY (K760311)Depuy, Inc.1976-08-09

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