Atlas FDA

FPO

50 FDA 510(k) clearances · Product code

63 daysmedian time to decision
227 days90th percentile
50clearances measured

FDA profile

Official device name
Stretcher, Wheeled
Device class
Class II (moderate risk)
Regulation
21 CFR 880.6910
Medical specialty
General Hospital
Adverse events (MAUDE)
2021: 874 · 2022: 694 · 2023: 1,028 · 2024: 956 · 2025: 916 · 2026: 518
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
POWER-LOAD COT FASTENER SYSTEM (K113598)Stryker Medical2011-12-20
IRSG I-MOVER FOR BEDS (K072598)International Retail Services Group, LLC2008-04-14
DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759) (K972528)Dyna Corp.1997-07-28
ADULT-PEDIATRIC TRANSPORT SYSTEM (K955766)International Biomedical, Inc.1996-08-07
HARE MODEL 2000 EZ LOADER MODEL 95555 (K962181)Dyna Corp.1996-08-01
WHEELED STRETCHER (K961437)Hill-Rom, Inc.1996-06-03
HILL-ROM AMBULATORY CARE PROCEDURAL STRETCHER (K952447)Hill-Rom, Inc.1995-11-22
EMERGENCY/ACCIDENT TROLLEY 550 (K946101)Hogan & Hartson1995-02-07
MODEL 792 CONVERGE, MODEL 793 VISION 2000 (K945431)Hausted, Inc.1995-01-25
MODEL 578 MOBILE SURGICAL STRETCHER (K943969)Hausted, Inc.1995-01-25
STRYKER POWERED STRETCHER (K942948)Stryker Corp.1995-01-24
PATIENT TROLLEY 545 (K943528)Merivaara Instrumentarium Corp.1994-10-04
PATIENT TROLLEY 540 (K943529)Merivaara Instrumentarium Corp.1994-10-04
FUTURA JUNIOR 300/310 (K943262)Merivaara Instrumentarium Corp.1994-09-29
STRYKER 8000 SURGERY STRETCHER (K943864)Stryker Medical1994-08-25
STRYKER AMBULANCE COT MODEL 6060 (K935297)Stryker Medical1994-02-18
MODEL 561 C-ARM PROCEDURES STRETCHER (K923730)Midmark Corp.1994-02-09
S-610 & 2-628 WHEELED SHOWER STRETCHERS (K933060)The Anthros Medical Group1994-02-04
STS 701 TRANSPORT STRETCHER (K933071)Wy'East Medical Corp.1994-01-26
I.V. LINK (K933366)Deville Laboratories, Inc.1994-01-10
FERNO-WASHINGTON AMBULANCE COT, 93ES SQUAD-MATE (K932260)Ferno1993-09-09
HILL-ROM VIA STRETCHER (P1300 - P1303) (K922808)Hill-Rom, Inc.1993-03-31
GENERAL PROCEDURAL STRETCHERS (P880- P886) (K922809)Hill-Rom, Inc.1993-03-31
STRYKER I.V. CADDY ACCESSORY DEVICE (K920704)Stryker Medical1992-03-23
ST5500 UNIVERSAL CARE STRETCHER (K914543)Lic Care, Inc.1992-01-08
MODEL #527 OPHTHALMIC STRETCHER (K904011)Midmark Corp.1990-10-03
HARE FOLDING BACK EMERGENCY STRETCHER (K902503)Dyna Corp.1990-06-26
WHEELED STRETCHER (K900872)Hospital Supply Co., Inc.1990-05-18
SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART (K895740)Lumex, Inc.1990-02-22
SHOWER STRETCHER W/WHEELS (K884759)Linido, Inc.1989-06-15
HARE ANY LEVEL COT (K881845)Dyna Industries, Inc.1988-06-03
MRI STRETCHER (K874332)Atomic Products Corp.1988-01-05
STRETCHER, WHEELED, MECHANICAL (K873181)Cambridge Technologies, Inc.1987-10-09
MERIVAARA EMERGENCY PATIENT TROLLEY #436 (K871556)Global Medical Prods, Inc.1987-04-30
MODEL 35-B ALL LEVEL COT (K864269)Ferno-Washington, Inc.1986-11-13
MERIVAARA PATIENT TROLLEY - MODEL #416 (K862959)Global Medical Prods, Inc.1986-09-25
EZ LOAD MODEL 30, ALL LEVEL COT (K862441)Ferno-Washington, Inc.1986-09-12
BETA MEDICAL PRODUCTS EMR-301 HYDRAULIC STRETCHER (K863083)Beta Medical Products Co.1986-09-03
LIC MOBILE TRANSPORT STRETCHERS (K861410)Lada Intl., Inc.1986-04-22
KEYMED OFFICE COUCH (K854304)Keymed, Inc.1985-11-12
THE KEYMED VARI-HEIGHT PATIENT COUCH (K853421)Keymed, Inc.1985-09-19
NON-MAGNETIC EXAMINATION TABLE FOR MAGNETIC RESONA (K844578)Engineering Dynamics Corp.1985-05-14
CENTURIAN HYDRAULIC STRETCHER (K843439)American Sterilizer Co.1984-09-13
KEYMED MOBILE ENDOSCOPY PATIENT COUCH (K840920)Keymed, Inc.1984-03-19
IURA UNIVERSAL HOSPITAL STRETCHER-HS-13 (K840124)Trade West, Inc.1984-01-27
IURA AMBULANCE STRETCHER IAS-1 (K840122)Trade West, Inc.1984-01-27
IURA UNIVERSAL WHEELCHAIR/STRETCHER- (K840125)Trade West, Inc.1984-01-27
PAD, HOSPITAL STRETCHER (K801935)Volunteer Blind Industries, Inc.1980-08-27
PATIENT TROLLEY B49 (K792570)Ets Rene Marzet1979-12-31
RELIANCE MOD-U-LINE M-700 (K761147)F. & F. Koenigkramer1977-01-28

Track FPO automatically

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