Atlas FDA

LDQ

81 FDA 510(k) clearances · Product code

65 daysmedian time to decision
254 days90th percentile
81clearances measured

FDA profile

Adverse events (MAUDE)
2002: 2 · 2005: 2 · 2007: 3 · 2009: 17 · 2020: 48 · 2021: 24
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
EC-7701 FLUID WARMING CABINET (K993797)Enthermics Medical Systems, Inc.2000-01-20
HOT SHOT FLUID WARMER IV FLUIDS (K992258)Infra-Med Technologies, Inc.2000-01-12
PIV SYSTEM (K981032)Medical Solutions, Inc.1998-09-02
CONTROLLED TEMPERATURE CABINET SYSTEM (K973747)Smith1998-05-07
ACU-HALT (K955661)Glederer & Co., Inc.1996-12-30
ACU-LAB (K955776)Glederer & Co., Inc.1996-06-05
ACU-HALT (K945374)Eva-Health USA, Inc.1995-08-09
PERSONAL ALARM SYSTEM (PAS) (K944961)Cytoprobe Corp.1995-08-07
PALCO LABS COLD POUCH (K942810)Palco Laboratories, Inc.1995-06-28
MEDICAL PROCEDURE TRAY, MODIFICATION (K930884)Enpak Medical Corp.1995-03-21
MEDICOOL PROTECTALL (K934703)Avc Regulatory Compliance/Technical Services1994-01-26
NORTEC STERILE WATER FOR DEVICE IRRIGATION (K925593)North American Sterilization & Packaging Co.1993-12-03
NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI (K925588)North American Sterilization & Packaging Co.1993-12-03
ELECTRONIC GLOVE INTEGRITY MONITOR (EGIM) (K932714)Surface Mount Technology, Inc.1993-12-01
ELPER(TM) BARRIER INTEGRITY MONITORING (K931153)Igea, S.R.L.1993-11-18
DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET (K924837)Associated Ent., Inc.1993-10-12
SURGIC-ALERT MONITOR (K930514)Novatec Medical Products, Inc.--Glove Monitor1993-08-19
GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT. (K915636)Associated Ent., Inc.1992-07-13
BARRIER INTEGRITY MONITOR (K915662)Incomed, Inc.1992-06-25
GLOVE-CHEK PORTABLE FLUID LEAKAGE SENSING DEVICE (K913696)Vertex Technical Group, Inc.1992-02-18
OLYMPIC WARMETTE (K911955)Olympic Medical Corp.1991-07-19
MEDICAL PROCEDURE TRAY (K902410)Sorex Medical1990-11-20
ACCU PATH STERILE LABEL (K904598)Accu-Path1990-10-30
STICK-GARD STERILE CAP (K902682)Integrated Medical Systems, Inc.1990-09-26
GLOVE LEAK DETECTOR (K901237)Utah Medical Products, Inc.1990-08-21
SHARP-SAFE, BIODEGRADEABLE,DISP., NEEDLE DISP. BOX (K901321)Sharp Safe, Inc.1990-05-11
WEINSTEIN STYLE INSTRUMENT HOLDER (K901486)David Ayres Medical Co.1990-05-02
MEDICOOL, CONTAINER FOR STORING INSULIN (K895674)Medicool, Inc.1990-01-11
UNIVERSAL LIGHT CABLE (K894570)Expanded Optics, Inc.1989-10-13
SIEMENS CEILING STAND 800F, 800 AND 810 (K891023)Siemens Medical Electronics1989-07-25
SARNS MEDICAL CART (K892052)3M Company1989-06-15
INSU COOL (K885055)Dynex Trading Co.1989-04-26
MULTI-PURPOSE HOLDER (K884630)Med-Dex Intl.1988-11-22
MR. RAZOR II TWIN (K882388)Burney Products Corp.1988-07-13
BLADE, SURGICAL PREP RAZOR STRAIGHT (K880048)Crescent Corp.1988-03-04
BOWL, SPONGE, DISPOSABLE, STERILE & NON-STERILE (K874186)Busse Hospital Disposables, Inc.1987-12-29
STERILABELS (K864015)Diversatronics, Inc.1986-12-12
SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES (K863633)Biological & Environmental Control Laboratories1986-10-16
STUART GILMAN'S WEIGHT LOSS PLAN (K854441)Alpha Therapeutic Corp.1986-02-10
CUDDLE CUSHION (K853185)The Cuddle Co.1985-08-20
STERILE GENERAL HOSPITAL SUPPLIES (K851390)Biological & Environmental Control Laboratories1985-05-29
ACTION PAC (K851276)South Mountain Medical1985-05-15
DISPOS. POLY APRONS (K842016)Abco Dealers, Inc.1984-07-03
STERILE LABELS (K834062)Devon Industries, Inc.1984-02-04
STERILE RUBBER BANDS (K834063)Devon Industries, Inc.1983-12-22
TOURNIQUET CUFF PRESSURE MONITOR #TCPM (K832272)Electromedics, Inc.1983-11-28
PLASTIC DISPOSABLE RAZOR (K831799)I M, Inc.1983-07-18
INFECTION CONTROL TOWEL (K822484)American Threshold Industries, Inc.1982-09-30
OUT-RITE WASTE DISPOSABLE BAG (K821396)Kleen Test Products1982-06-09
CARDIO-BAND (K813566)Cardio-Band, Inc.1982-02-22
SAFETY PINS (K820052)Stan-Pak Ent.1982-02-04
TRACHEOSTOMY CARE TRAY (K813260)E.M. Adams1981-12-31
POSTURE MIRROR (K812479)Maddak, Inc.1981-12-09
STERILE BASIN SETS (K813012)Medspec Corp.1981-11-06
FOAM WEDGE (K812482)Maddak, Inc.1981-09-24
CUDDLE CAP (K812216)Darcy, Inc.1981-08-20
MINOR DRESSING TRAY (K811091)Cunningham Woodland, Inc.1981-05-08
MAJOR DRESSING TRAY (K811090)Cunningham Woodland, Inc.1981-05-08
DRESSING TRAY MERCY HOSPITAL (K811088)Cunningham Woodland, Inc.1981-05-08
ONE STEP PREP KIT (K811089)Cunningham Woodland, Inc.1981-05-08
DRESSING CHANGE TRAY-MEDIUM (K810570)Associated Medical Products Co.1981-03-30
DR. MICHAEL'S FOOT HELPER (K802837)Dr. Michael'S Foot-Care Products1980-12-10
AMPCO SHAVE PREP TRAYS, CAT.#SP4020 (K802041)Associated Medical Products Co.1980-10-23
NU-BORN BABY BATH KIT (K802366)American Hospital Supply Corp.1980-10-10
AMPCO SKIN SCRUB TRAYS, CAT.#SS824 (K802042)Associated Medical Products Co.1980-09-16
AMPCO SKIN SCRUB TRAYS, CAT.#SS843 (K802043)Associated Medical Products Co.1980-09-16
PLASTIC DISPOSABLE RAZOR CAT.#1017,1018 (K802003)Pollak (Intl.), Ltd.1980-09-09
AMPCO SKIN SCRUB TRAYS, CAT.#SS612 (K802044)Associated Medical Products Co.1980-09-09
TUBE HOLDER (K801421)Devon Industries, Inc.1980-07-28
CONPHAR SURGICAL RAZORR (K791798)Conphar, Inc.1980-02-01
SANDEE SANDING BLOCK (K790504)Dr. Bertram L. Steel1979-06-11
KAGER TRAPDUST (K790085)Kager Intl.1979-05-29
SURGICAL PREP RAZOR (K781437)Warren J. Grosjean1978-12-05
RAISED TOILET SEAT (K772276)Med Fusion Systems, Inc.1978-03-14
TOILET SAFETY RAIL (K772275)Med Fusion Systems, Inc.1978-03-14
CUT-DOWN BUILT-UP TOILET SEAT (K772403)Fred Sammons, Inc.1978-02-21
ISOLATION KIT (K770381)American Hospital Supply Corp.1977-04-05
RAZOR, SCHICK DISPOSABLE (K760342)Parke-Davis Co.1976-08-11
RAZOR, DISPOSABLE (K760328)Devon Industries, Inc.1976-08-11
BASIN, WASH, 6-QT RECTANGULAR (K760073)Bemis Health Care1976-07-20
KIT, PREP SHAVE (K760052)M-C Ind., Inc.1976-07-16

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