FDA product code FNL: Bed, Ac-Powered Adjustable Hospital
FNL is the FDA product code for bed, ac-powered adjustable hospital. It is a Class II device, regulated under 21 CFR 880.5100 and reviewed by the General Hospital panel. FDA has cleared 70 510(k) submissions under FNL, from 41 different applicants. The average 510(k) review took 110 days (median 84). FDA has posted 155 recalls for FNL devices, 24 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bed, Ac-Powered Adjustable Hospital |
| Device class | Class II |
| Regulation | 21 CFR 880.5100 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
510(k) clearances per year for FNL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 261 |
Compare with all 510(k) review times · Search every FNL clearance
Top FNL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Med Service, Inc. | 6 | 1988-11-01 |
| Hill-Rom, Inc. | 5 | 1997-02-03 |
| Carrom Healthcare, Inc. | 4 | 1986-02-04 |
| Vail Products, Inc. | 3 | 1998-10-05 |
| Kinetic Concepts, Inc. | 3 | 1995-02-16 |
36 more applicants have FNL clearances. See the full list in Caduvo.
Most recent FNL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K202964 | Stryker Corporation | iBed Wireless with iBed Mobile | 2021-06-18 | 261 |
| K103536 | Stryker Corporation | IBED WIRELESS WITH IBED AWARENESS | 2010-12-16 | 15 |
| K982783 | Vail Products, Inc. | VAIL 1000 ENCLOSED BED | 1998-10-05 | 59 |
| K974296 | Invacare Corp. | MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BED | 1998-01-06 | 50 |
| K974254 | M.C. Healthcare Products, Inc. | BENEFIT B3--- SERIES | 1997-12-16 | 33 |
Recalls for FNL devices
155 product recalls in 93 recall events; 24 initiated in the last five years and 27 still open. Most recent: 2026-05-04.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 5 |
| 2019 | 1 |
| 2020 | 5 |
| 2021 | 6 |
| 2022 | 5 |
| 2023 | 17 |
| 2024 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code FNL?
FNL is the FDA product code for bed, ac-powered adjustable hospital. It is a Class II device, regulated under 21 CFR 880.5100 and reviewed by the General Hospital panel.
What device class is FNL?
Class II, regulation 21 CFR 880.5100. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FNL?
Across 70 cleared submissions the average was 110 days from receipt to decision (median 84).
Which companies have the most FNL clearances?
Med Service, Inc. (6); Hill-Rom, Inc. (5); Carrom Healthcare, Inc. (4); Vail Products, Inc. (3); Kinetic Concepts, Inc. (3).
Have FNL devices been recalled?
Yes: 155 product recalls across 93 recall events; the most recent began 2026-05-04.
Next steps
- Run an FDA pathway report with predicate devices for product code FNL
- Run a recall and safety report across every FNL manufacturer
- Watch product code FNL 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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