FDA product code FMS: Bed, Pediatric Open Hospital
FMS is the FDA product code for bed, pediatric open hospital. It is a Class II device, regulated under 21 CFR 880.5140 and reviewed by the General Hospital panel. FDA has cleared 27 510(k) submissions under FMS, from 18 different applicants. The average 510(k) review took 134 days (median 83). FDA has posted 5 recalls for FMS devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bed, Pediatric Open Hospital |
| Device class | Class II |
| Regulation | 21 CFR 880.5140 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FMS clearance
Top FMS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Infant Advantage, Inc. | 5 | 1997-04-25 |
| Pedicraft, Inc. | 3 | 1993-04-20 |
| International Purchasing Services | 3 | 1986-04-23 |
| Janco Consulting Services | 2 | 1995-02-10 |
| Vail Products, Inc. | 1 | 1996-11-13 |
13 more applicants have FMS clearances. See the full list in Caduvo.
Most recent FMS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K970334 | Infant Advantage, Inc. | NATURE'S CRADLE | 1997-04-25 | 87 |
| K963210 | Vail Products, Inc. | VAIL 100 PEDIATRIC CRIB | 1996-11-13 | 89 |
| K960747 | Infant Advantage, Inc. | NATURE'S CRADLE MODEL C1500 | 1996-05-22 | 89 |
| K960012 | Stryker Corp. | STRYKER ADEL BASSINET | 1996-03-25 | 83 |
| K951024 | Infant Advantage, Inc. | NATURE'S CRADLE | 1995-06-05 | 91 |
Recalls for FMS devices
5 product recalls in 4 recall events; 1 initiated in the last five years and 2 still open. Most recent: 2026-02-18.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2021 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code FMS?
FMS is the FDA product code for bed, pediatric open hospital. It is a Class II device, regulated under 21 CFR 880.5140 and reviewed by the General Hospital panel.
What device class is FMS?
Class II, regulation 21 CFR 880.5140. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FMS?
Across 27 cleared submissions the average was 134 days from receipt to decision (median 83).
Which companies have the most FMS clearances?
Infant Advantage, Inc. (5); Pedicraft, Inc. (3); International Purchasing Services (3); Janco Consulting Services (2); Vail Products, Inc. (1).
Have FMS devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2026-02-18.
Next steps
- Run an FDA pathway report with predicate devices for product code FMS
- Run a recall and safety report across every FMS manufacturer
- Watch product code FMS 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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