FDA product code FPO: Stretcher, Wheeled
FPO is the FDA product code for stretcher, wheeled. It is a Class II device, regulated under 21 CFR 880.6910 and reviewed by the General Hospital panel. FDA has cleared 50 510(k) submissions under FPO, from 32 different applicants. The average 510(k) review took 100 days (median 60). FDA has posted 76 recalls for FPO devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Stretcher, Wheeled |
| Device class | Class II |
| Regulation | 21 CFR 880.6910 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every FPO clearance
Top FPO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Stryker Medical | 4 | 2011-12-20 |
| Hill-Rom, Inc. | 4 | 1996-06-03 |
| Dyna Corp. | 3 | 1997-07-28 |
| Merivaara Instrumentarium Corp. | 3 | 1994-10-04 |
| Keymed, Inc. | 3 | 1985-11-12 |
27 more applicants have FPO clearances. See the full list in Caduvo.
Most recent FPO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K113598 | Stryker Medical | POWER-LOAD COT FASTENER SYSTEM | 2011-12-20 | 15 |
| K072598 | International Retail Services Group, LLC | IRSG I-MOVER FOR BEDS | 2008-04-14 | 213 |
| K972528 | Dyna Corp. | DYNA GLIDE 2600 ROLL-IN AMBULANCE COT (95759) | 1997-07-28 | 21 |
| K955766 | International Biomedical, Inc. | ADULT-PEDIATRIC TRANSPORT SYSTEM | 1996-08-07 | 231 |
| K962181 | Dyna Corp. | HARE MODEL 2000 EZ LOADER MODEL 95555 | 1996-08-01 | 56 |
Recalls for FPO devices
76 product recalls in 35 recall events; 7 initiated in the last five years and 10 still open. Most recent: 2026-06-19.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 4 |
| 2021 | 3 |
| 2022 | 2 |
| 2023 | 3 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code FPO?
FPO is the FDA product code for stretcher, wheeled. It is a Class II device, regulated under 21 CFR 880.6910 and reviewed by the General Hospital panel.
What device class is FPO?
Class II, regulation 21 CFR 880.6910. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FPO?
Across 50 cleared submissions the average was 100 days from receipt to decision (median 60).
Which companies have the most FPO clearances?
Stryker Medical (4); Hill-Rom, Inc. (4); Dyna Corp. (3); Merivaara Instrumentarium Corp. (3); Keymed, Inc. (3).
Have FPO devices been recalled?
Yes: 76 product recalls across 35 recall events; the most recent began 2026-06-19.
Next steps
- Run an FDA pathway report with predicate devices for product code FPO
- Run a recall and safety report across every FPO manufacturer
- Watch product code FPO 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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