MOD — Accessory To Continuous Ventilator (Respirator) Class II
FDA product code MOD covers "Accessory To Continuous Ventilator (Respirator)", a Class II medical device regulated under 21 CFR 868.5895. Submissions are reviewed by the Anesthesiology panel. At least 16 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MOD
- Device Class
- Class II
- Regulation Number
- 868.5895
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261360 | resmed | EasyCare Tx 2 | August 27, 2026 |
| K253807 | convergence medical sciences | Valence InVent Xtend (CVG-4101-VXA) | August 20, 2026 |
| K260051 | corvent® medical | CorVision® (91-205-Z0014) | May 12, 2026 |
| K242485 | breas medical | EveryWare | May 20, 2025 |
| K161411 | respironics | Care Cycle Connect Application | February 17, 2017 |
| K091461 | cardiopulmonary | BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE | August 14, 2009 |
| K052751 | mediserve information systems | VENTLINK SYSTEM | December 23, 2005 |
| K052244 | innovision medical technologies | IISIS, VERSION 1.0 | October 13, 2005 |
| K040712 | air safety | AIR SAFETY HEPA, MODEL 3500 | June 3, 2004 |
| K022062 | impact instrumentation | IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 | May 6, 2003 |
| K010401 | medical device group | TRI-PLEX ADAPTER | October 30, 2002 |
| K011861 | cardiopulmonary | BERNOULLI VENTILATOR MANAGEMENT SYSTEM | November 6, 2001 |
| K963633 | puritan bennett | VENTNET; CENTRAL MONITORING STATION | December 16, 1996 |
| K935788 | bicore monitoring systems | BICORE SMARTCATH INTRATRACHEAL CATHETER | July 3, 1995 |
| K936156 | smith industries medical systems (sims) | VENTILATION MECHANICS MONITOR MODEL VMM-100 | June 27, 1995 |
| K940739 | newport medical instruments | NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR | March 7, 1995 |