Atlas FDA

FSA

13 FDA 510(k) clearances · Product code

40 daysmedian time to decision
183 days90th percentile
13clearances measured

FDA profile

Official device name
Lift, Patient, Non-Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 880.5510
Medical specialty
General Hospital
Adverse events (MAUDE)
2021: 257 · 2022: 264 · 2023: 342 · 2024: 371 · 2025: 438 · 2026: 974
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SURGICAL LIFT SHEET (K942807)Surgin Surgical Instrumentation, Inc.1994-08-02
SANITAS PATIENT LIFT (K930625)Dutton-Lainson Co.1993-09-13
ANOLIFT - PORTABLE & ANOLIFT - GANTRY (K902141)Anodyne Corp.1990-09-12
HOYER ONE-TOUCH POWER LIFTER (K860837)Ted Hoyer & Co., Inc.1986-03-27
MOLIFT (K851844)Madshus A/S1985-05-17
MEDI-MAN WATER POWERED BATH LIFT & HYDRAULIC LIFT (K844976)Medi-Man Rehabilitation Products, Inc.1985-04-01
SHOWER TROLLEY (K841395)Setma, Inc.1984-05-07
VARIABLE HEIGHT TRANSFER CHAIR (K841398)Setma, Inc.1984-05-07
BATTERY POWERED PATIENT LIFT (K840997)Invacare Corp.1984-04-17
MARTIN PELVIC LIFT (K823206)Martin Pelvic Lift Co.1983-04-28
CENTURY LIFT TRANSFER SYSTEM (K811899)Century Manufacturing Co.1981-07-23
LIFELIFT MODELS ONE AND TWO (K792601)Corda Int'L Holiday, Inc.1979-12-31
PATIENT LIFT (K780684)Orthopedic Equipment Co., Inc.1978-06-06

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