FDA product code CAI: Circuit, Breathing (W Connector, Adaptor, Y Piece)
CAI is the FDA product code for circuit, breathing (w connector, adaptor, y piece). It is a Class I device, regulated under 21 CFR 868.5240 and reviewed by the Anesthesiology panel. FDA has cleared 184 510(k) submissions under CAI, from 84 different applicants. The average 510(k) review took 69 days (median 50). FDA has posted 205 recalls for CAI devices, 40 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Circuit, Breathing (W Connector, Adaptor, Y Piece) |
| Device class | Class I |
| Regulation | 21 CFR 868.5240 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CAI clearance
Top CAI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mag, Inc. | 15 | 1994-06-22 |
| Sigma Medical, Inc. | 13 | 1985-09-03 |
| Life Shield Healthcare Products, Inc. | 10 | 1993-07-23 |
| Precision Med Products, Ltd. | 10 | 1993-07-23 |
| Med-Plastics Intl., Inc. | 9 | 1994-06-10 |
79 more applicants have CAI clearances. See the full list in Caduvo.
Most recent CAI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K954480 | Nova-Ventrx | CONDENSATE COLLECTION KIT | 1995-12-29 | 94 |
| K953788 | Unicor, Inc. | UNICOR, INC. GAS SAMPLING LINES & CONNECTORS | 1995-09-19 | 36 |
| K953787 | Unicor, Inc. | UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUIT | 1995-09-19 | 36 |
| K952020 | Prima, Inc. | PRIMA PEDIATRIC ANESTHESIA CIRCUITS | 1995-05-22 | 24 |
| K952017 | Prima, Inc. | PRIMA MAPLESON D CIRCUIT | 1995-05-22 | 24 |
Recalls for CAI devices
205 product recalls in 39 recall events; 40 initiated in the last five years and 28 still open. Most recent: 2026-08-11.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2022 | 1 |
| 2023 | 15 |
| 2024 | 6 |
| 2025 | 8 |
| 2026 | 10 |
Frequently asked questions
What is FDA product code CAI?
CAI is the FDA product code for circuit, breathing (w connector, adaptor, y piece). It is a Class I device, regulated under 21 CFR 868.5240 and reviewed by the Anesthesiology panel.
What device class is CAI?
Class I, regulation 21 CFR 868.5240. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CAI?
Across 184 cleared submissions the average was 69 days from receipt to decision (median 50).
Which companies have the most CAI clearances?
Mag, Inc. (15); Sigma Medical, Inc. (13); Life Shield Healthcare Products, Inc. (10); Precision Med Products, Ltd. (10); Med-Plastics Intl., Inc. (9).
Have CAI devices been recalled?
Yes: 205 product recalls across 39 recall events; the most recent began 2026-08-11.
Next steps
- Run an FDA pathway report with predicate devices for product code CAI
- Run a recall and safety report across every CAI manufacturer
- Watch product code CAI 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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