FDA product code MOD: Accessory To Continuous Ventilator (Respirator)
MOD is the FDA product code for accessory to continuous ventilator (respirator). It is a Class II device, regulated under 21 CFR 868.5895 and reviewed by the Anesthesiology panel. FDA has cleared 16 510(k) submissions under MOD, 4 in the last five years, from 15 different applicants. The average 510(k) review took 253 days (median 205); 222 days on average over the last three years. FDA has posted 1 recall for MOD devices.
Classification
| Field | Value |
|---|---|
| Device name | Accessory To Continuous Ventilator (Respirator) |
| Device class | Class II |
| Regulation | 21 CFR 868.5895 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MOD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 273 |
| 2025 | 1 | 272 |
| 2026 | 3 | 171 |
Compare with all 510(k) review times · Search every MOD clearance
Top MOD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cardiopulmonary Corp. | 2 | 2009-08-14 |
| Resmed Corp | 1 | 2026-08-27 |
| Convergence Medical Sciences , Ltd. | 1 | 2026-08-20 |
| CorVent® Medical, Inc. | 1 | 2026-05-12 |
| Breas Medical AB | 1 | 2025-05-20 |
10 more applicants have MOD clearances. See the full list in Caduvo.
Most recent MOD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261360 | Resmed Corp | EasyCare Tx 2 | 2026-08-27 | 125 |
| K253807 | Convergence Medical Sciences , Ltd. | Valence InVent Xtend (CVG-4101-VXA) | 2026-08-20 | 265 |
| K260051 | CorVent® Medical, Inc. | CorVision® (91-205-Z0014) | 2026-05-12 | 124 |
| K242485 | Breas Medical AB | EveryWare | 2025-05-20 | 272 |
| K161411 | Respironics, Inc. | Care Cycle Connect Application | 2017-02-17 | 273 |
Recalls for MOD devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-06-08.
Frequently asked questions
What is FDA product code MOD?
MOD is the FDA product code for accessory to continuous ventilator (respirator). It is a Class II device, regulated under 21 CFR 868.5895 and reviewed by the Anesthesiology panel.
What device class is MOD?
Class II, regulation 21 CFR 868.5895. Typical premarket route: 510(k).
How long does a 510(k) take for product code MOD?
Across 16 cleared submissions the average was 253 days from receipt to decision (median 205).
Which companies have the most MOD clearances?
Cardiopulmonary Corp. (2); Resmed Corp (1); Convergence Medical Sciences , Ltd. (1); CorVent® Medical, Inc. (1); Breas Medical AB (1).
Have MOD devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2005-06-08.
Next steps
- Run an FDA pathway report with predicate devices for product code MOD
- Run a recall and safety report across every MOD manufacturer
- Watch product code MOD 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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