FDA product code FCO: Box, Battery, Rechargeable
FCO is the FDA product code for box, battery, rechargeable. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 20 510(k) submissions under FCO, from 3 different applicants. The average 510(k) review took 134 days (median 116).
Classification
| Field | Value |
|---|---|
| Device name | Box, Battery, Rechargeable |
| Device class | Class I |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Top FCO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| R & D Batteries, Inc. | 17 | 1995-03-23 |
| National Custom Ent., Inc. | 2 | 1994-11-04 |
| Portable Power Systems, Inc. | 1 | 1995-08-02 |
Most recent FCO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K946080 | Portable Power Systems, Inc. | PHYSIO CONTROL LIFEPAK 200 AUTO DEFIBRILLATOR | 1995-08-02 | 232 |
| K945870 | R & D Batteries, Inc. | R&D PART NOS. 5490, 5541, 5358, 5497 | 1995-03-23 | 112 |
| K944388 | R & D Batteries, Inc. | R&D BATTERIES PART NOS. 5116, 5124, 5099, 5100 | 1995-03-23 | 197 |
| K944348 | R & D Batteries, Inc. | R&D BATTERIES, INC. PART NO. 5128, 5053, 5007 | 1995-03-23 | 198 |
| K944389 | R & D Batteries, Inc. | R&D BATTERIES PART NOS. 5111, 5112, 5065, 5153 | 1995-03-23 | 197 |
Recalls for FCO devices
openFDA lists no recalls for product code FCO.
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system
Frequently asked questions
What is FDA product code FCO?
FCO is the FDA product code for box, battery, rechargeable. It is a Class I device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is FCO?
Class I, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code FCO?
Across 20 cleared submissions the average was 134 days from receipt to decision (median 116).
Which companies have the most FCO clearances?
R & D Batteries, Inc. (17); National Custom Ent., Inc. (2); Portable Power Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FCO
- Run a recall and safety report across every FCO manufacturer
- Watch product code FCO 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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