Atlas FDA

LRP

22 FDA 510(k) clearances · Product code

63 daysmedian time to decision
260 days90th percentile
22clearances measured

FDA profile

Official device name
Tray, Surgical
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2011: 20 · 2012: 10 · 2013: 50 · 2015: 15 · 2017: 20 · 2024: 20
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
LACERATION TRAY (K963723)Grand Medical Products1996-11-27
OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK (K951811)Osteotech, Inc.1995-05-31
EYE TRAY (K940239)Cush Medical Products1994-06-28
CUSTOM ENT PACKS (K935621)Associated Medical1994-03-30
ORTHOPEDIC TRAY PRODUCT LINE (K940646)Cushindu1994-03-11
GENERAL SURGERY TRAY (K940444)Cush Medical Products1994-03-07
HOSPITAL KIT ENT 1125 (K922126)Savoy Medical Supply Co., Inc.1993-01-21
EYE TRAY (K912105)Medical Device Inspection Co., Inc.1991-08-29
KITS AND TRAYS FOR ONE TIME USE ONLY (K903963)Apk Technology1991-07-29
INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE (K903962)Apk Technology1991-07-29
PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES (K905462)Angiosystems, Inc.1991-02-06
CAREKITS(TM) INCISION/DRAINAGE/SUTURE REMOVAL KITS (K903544)J.J. Skinner, Inc.1990-08-31
STERILE LACERATION TRAY (K890071)Mumtaz I. Malik1989-01-24
SITE STERILIZATION TRAYS FOR OPHTHALMIC USE (K883098)Site Microsurgical Systems, Inc.1988-08-18
STERILE PACK (PROCEDURAL TRAY/KITS) (K882275)East Texas Lighthouse For the Blind1988-07-18
KOI(TM) INSTRUMENT TRAYS (K881095)CooperVision, Inc.1988-04-06
SECURLINE FINE NEEDLE ASPIRATION BIOPSY TRAY (K874665)Precision Dynamics Corp.1988-01-20
TODD MEDICAL/SKILLED CARE PRODUCTS (K873469)Todd Medical, Inc.1987-10-29
LACERATION AND INSTRUMENT TRAYS (K873290)Advantage Medical Systems, Inc.1987-09-24
LACERATION TRAY (K873439)Ulti-Med Intl., Inc.1987-09-11
MASTER KIT B (K861142)Pro-Lab, Inc.1986-07-10
TRAY, SERVICE (K760497)Landmark Plastics1976-11-12

Track LRP automatically

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