Atlas FDA

KDD

62 FDA 510(k) clearances · Product code

60 daysmedian time to decision
221 days90th percentile
62clearances measured

FDA profile

Official device name
Kit, Surgical Instrument, Disposable
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2020: 44 · 2021: 63 · 2023: 43 · 2024: 58 · 2025: 34 · 2026: 31
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
CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES (K072814)Covidien2008-04-16
INSTRUMENTS FOR ONE TIME USE - DISPOSABLE (K011514)Kencap , Ltd.2001-08-13
NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS (K971317)National Healthcare Mfg. Corp.1997-05-08
DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY (K960456)Denver Biomaterials, Inc.1996-04-01
CUSTOM CV PACK (K936255)Associated Medical1994-03-31
SUTURE SET OR LACERATION TRAYS (PACKS) (K932219)Associated Medical Products Co.1993-07-09
SURGICAL INSTRUMENT KIT, DISPOSABLE (K923176)Ulti-Med Intl., Inc.1993-06-17
KIT, SURGICAL INSTRUMENT, DISPOSABLE (K925905)Kay Medical Concepts1993-06-16
BIOPSY/MYELO/ARTHRO/AMNIOCENT/BASIC SKIN PREP TRAY (K924958)Medical Insights, Inc.1993-06-07
STERILE SURGICAL INSTRUMENT TRAYS (K925215)American Healthcare Supply Co., Inc.1993-06-01
DEXIDE LAPAROSCOPIC KITS (K924117)Dexide, Inc.1993-03-23
SURGICAL INSTRUMENT KIT, DISPOSABLE (K920989)Ulti-Med Intl., Inc.1992-10-19
LACERATTION TRAY (K920763)Sterile Concepts, Inc.1992-09-28
GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB (K920516)Trinity Laboratories, Inc.1992-04-16
STERILE CUSTOM SURGICAL KITS (K914244)Ulti-Med Intl., Inc.1992-02-24
SLIP-PRUF-CLINGER (K913049)Macbrud Corp. Medical Div.1991-09-11
BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES (K911606)Baxter Healthcare Corp1991-07-09
IN-SIGHT SURGICAL INSTRUMENT KITS, DISPOSABLE (K910816)Insight International, Inc.1991-04-17
MEGA GENERAL PURPOSE INSTRUMENT KIT (K910366)Megadyne Medical Products, Inc.1991-03-28
INCISION AND DRAINAGE KIT (K910369)Megadyne Medical Products, Inc.1991-03-28
DISPOSABLE PROCEDURAL TRAYS #CK-XXXXX (VARIOUS) (K902441)Currie Medical Specialties, Inc.1990-08-23
SKILCRAFT (K880785)Pennsylvania Association For the Blind1988-03-11
ENTERON ABDOMINAL PARACENTESIS TRAY (K874063)Endovations1987-12-04
SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW (K871458)Fraass Survival Systems, Inc.1987-07-09
STERILE PROCEDURAL TRAYS (K870373)Dimed, Intl.1987-03-20
JMS HALO APPLICATION TRAY (K864969)Jerome Medical1987-02-18
SUTURE REMOVAL KIT (K853910)Scientific & Medical Care Co.1985-10-08
COOK COUNTY HOSPITAL DRESSING CHANGE SET (K843206)Geneva Laboratories, Inc.1985-05-24
STERILE SUTURE REMOVAL KIT (K850325)Excel Health Care Products1985-02-26
C-SECTION TRAY (K842627)Deroyal Industries, Inc.1984-09-26
STERILE SOLUTION BOWL (K843115)E.M. Adams1984-09-07
STERILE SUTURE BOOTS (K834135)Devon Industries, Inc.1984-04-27
PREPACELL-STERILE-BONE MARROW ASPIR (K833438)Applied Medical Devices, Inc.1984-02-09
VYGON THORACIC DRAINAGE-VARIOUS #'S (K832628)Exco, Inc.1984-01-30
WET DRESSING KIT (K833075)Clinipad Corp.1984-01-27
STERILE WET DRESSING PACK (K834532)W.G. Whitney Corp.1984-01-25
STERILE DISP. INSTRUMENT TRAYS (K831841)E.M. Adams1983-12-14
STERILE SUTURE REMOVAL SET (K832047)Ormed Mfg., Inc.1983-09-12
FIRST AID KITS (K831795)I M, Inc.1983-09-01
RESCUE PACK (K830374)Akla, Inc.1983-05-13
OPEN HEART TRAY (CUSTOM DESIGNED) (K822158)Megaplast, Inc.1982-10-13
HEMO-NATE L-P KIT (K821814)Int'L Corp.1982-07-09
STERILE SUTURE REMOVAL KIT (K821502)Pro-Pak1982-07-09
STERILE CATH CARE KIT (K821500)Pro-Pak1982-06-23
STERILE TRACHEOSTOMY CARE KIT (K821501)Pro-Pak1982-06-16
SUTURE REMOVAL TRAY (K820423)Megaplast, Inc.1982-03-10
ACKRAD INCISION & DRAIN SET (K813103)Ackrad Laboratories1981-12-09
SKIN SCRUB KITS (K811855)Oem Medical Div.1981-07-31
SUTURE REMOVAL SET(DISPLSABLE) (K811086)Cunningham Woodland, Inc.1981-05-01
SUTURE REMOVAL KIT (K803199)Walpak Co.1981-01-15
LARGE WOUND DRESSING KIT (K803119)American Medical Disposable, Inc.1980-12-30
CUSTOM DRESSING TRAY WET TO DRY (K803117)American Medical Disposable, Inc.1980-12-23
SIMPLE DRESSING TRAY #82028 (K803118)American Medical Disposable, Inc.1980-12-22
EMERGENCY DEPARTMENT LACERATION KIT- (K802557)Johnson & Johnson Professionals, Inc.1980-11-12
DRESSING CHANGE SET CAT.#910-930 (K802017)Pollak (Intl.), Ltd.1980-10-10
SUTURE REMOVAL SET CAT.#906 (K802019)Pollak (Intl.), Ltd.1980-09-16
INSTRUMENT AND ACCESSORY KIT (K780488)American Hospital Supply Corp.1978-04-12
URINE SAMPLE KIT (K780336)American Hospital Supply Corp.1978-04-03
STERILE SUTURE REMOVAL KIT (K771448)Premium Plastics, Inc.1977-09-06
MAJOR SUTURE REMOVAL TRAY (K770149)Pharmaseal Div., Baxter Healthcare Corp.1977-02-25
SUTURE REMOVAL KIT (K761193)Superior Plastic Products Corp.1977-01-12
TRAY, SUTURE REMOVAL (K760051)M-C Ind., Inc.1976-08-30

Track KDD automatically

Every clearance here is in the API, with alerts when new ones post.