FDA product code FSA: Lift, Patient, Non-Ac-Powered
FSA is the FDA product code for lift, patient, non-ac-powered. It is a Class I device, regulated under 21 CFR 880.5510 and reviewed by the General Hospital panel. FDA has cleared 13 510(k) submissions under FSA, from 12 different applicants. The average 510(k) review took 69 days (median 40). FDA has posted 141 recalls for FSA devices, 21 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Lift, Patient, Non-Ac-Powered |
| Device class | Class I |
| Regulation | 21 CFR 880.5510 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FSA clearance
Top FSA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Setma, Inc. | 2 | 1984-05-07 |
| Surgin Surgical Instrumentation, Inc. | 1 | 1994-08-02 |
| Dutton-Lainson Co. | 1 | 1993-09-13 |
| Anodyne Corp. | 1 | 1990-09-12 |
| Ted Hoyer & Co., Inc. | 1 | 1986-03-27 |
7 more applicants have FSA clearances. See the full list in Caduvo.
Most recent FSA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K942807 | Surgin Surgical Instrumentation, Inc. | SURGICAL LIFT SHEET | 1994-08-02 | 49 |
| K930625 | Dutton-Lainson Co. | SANITAS PATIENT LIFT | 1993-09-13 | 217 |
| K902141 | Anodyne Corp. | ANOLIFT - PORTABLE & ANOLIFT - GANTRY | 1990-09-12 | 120 |
| K860837 | Ted Hoyer & Co., Inc. | HOYER ONE-TOUCH POWER LIFTER | 1986-03-27 | 22 |
| K851844 | Madshus A/S | MOLIFT | 1985-05-17 | 21 |
Recalls for FSA devices
141 product recalls in 87 recall events; 21 initiated in the last five years and 28 still open. Most recent: 2026-03-10.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 6 |
| 2019 | 6 |
| 2020 | 3 |
| 2021 | 11 |
| 2022 | 3 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 9 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code FSA?
FSA is the FDA product code for lift, patient, non-ac-powered. It is a Class I device, regulated under 21 CFR 880.5510 and reviewed by the General Hospital panel.
What device class is FSA?
Class I, regulation 21 CFR 880.5510. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FSA?
Across 13 cleared submissions the average was 69 days from receipt to decision (median 40).
Which companies have the most FSA clearances?
Setma, Inc. (2); Surgin Surgical Instrumentation, Inc. (1); Dutton-Lainson Co. (1); Anodyne Corp. (1); Ted Hoyer & Co., Inc. (1).
Have FSA devices been recalled?
Yes: 141 product recalls across 87 recall events; the most recent began 2026-03-10.
Next steps
- Run an FDA pathway report with predicate devices for product code FSA
- Run a recall and safety report across every FSA manufacturer
- Watch product code FSA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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