FDA product code BTC: Bag, Reservoir
BTC is the FDA product code for bag, reservoir. It is a Class I device, regulated under 21 CFR 868.5320 and reviewed by the Anesthesiology panel. FDA has cleared 19 510(k) submissions under BTC, from 18 different applicants. The average 510(k) review took 43 days (median 37). FDA has posted 7 recalls for BTC devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bag, Reservoir |
| Device class | Class I |
| Regulation | 21 CFR 868.5320 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
510(k) clearances per year for BTC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 117 |
Compare with all 510(k) review times · Search every BTC clearance
Top BTC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Warne Surgical Products, Ltd. | 2 | 1984-04-18 |
| Pedia, LLC | 1 | 2018-09-25 |
| Zefon Medical Products | 1 | 1994-05-27 |
| Merit Medical Systems, Inc. | 1 | 1993-07-16 |
| Med-Plastics Intl., Inc. | 1 | 1993-07-16 |
13 more applicants have BTC clearances. See the full list in Caduvo.
Most recent BTC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K181424 | Pedia, LLC | PeDIA | 2018-09-25 | 117 |
| K940220 | Zefon Medical Products | REBREATHER BAGS | 1994-05-27 | 126 |
| K932496 | Precision Med Products, Ltd. | PRECISION MED PRODUCTS, LTD. BREATHING BAGS | 1993-07-16 | 52 |
| K932584 | Merit Medical Systems, Inc. | BREATHING BAGS | 1993-07-16 | 50 |
| K932581 | Med-Plastics Intl., Inc. | BREATHING BAGS | 1993-07-16 | 50 |
Recalls for BTC devices
7 product recalls in 4 recall events; 2 initiated in the last five years and 0 still open. Most recent: 2023-04-17.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code BTC?
BTC is the FDA product code for bag, reservoir. It is a Class I device, regulated under 21 CFR 868.5320 and reviewed by the Anesthesiology panel.
What device class is BTC?
Class I, regulation 21 CFR 868.5320. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BTC?
Across 19 cleared submissions the average was 43 days from receipt to decision (median 37).
Which companies have the most BTC clearances?
Warne Surgical Products, Ltd. (2); Pedia, LLC (1); Zefon Medical Products (1); Merit Medical Systems, Inc. (1); Med-Plastics Intl., Inc. (1).
Have BTC devices been recalled?
Yes: 7 product recalls across 4 recall events; the most recent began 2023-04-17.
Next steps
- Run an FDA pathway report with predicate devices for product code BTC
- Run a recall and safety report across every BTC manufacturer
- Watch product code BTC 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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