Panels › Anesthesiology › Product code MOD · Class 2
Accessory To Continuous Ventilator (Respirator)
Regulation 868.5895
3510(k)s in 12 months (16 all time)
1recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in MOD
| Company | 510(k)s | Recalls |
|---|---|---|
| Cardiopulmonary Corp. | 2 | 0 |
| The Medical Device Group, Inc. | 1 | 1 |
| Air Safety, Ltd. | 1 | 0 |
| Bicore Monitoring Systems | 1 | 0 |
| Breas Medical AB | 1 | 0 |
| Convergence Medical Sciences , Ltd. | 1 | 0 |
| CorVent® Medical, Inc. | 1 | 0 |
| Impact Instrumentation, Inc. | 1 | 0 |
| Innovision Medical Technologies, LLC | 1 | 0 |
| Mediserve Information Systems, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 27, 2026 | K261360 | EasyCare Tx 2 Resmed Corp | MOD |
| Aug 20, 2026 | K253807 | Valence InVent Xtend (CVG-4101-VXA) Convergence Medical Sciences , Ltd., CA | MOD |
| May 12, 2026 | K260051 | CorVision® (91-205-Z0014) CorVent® Medical, Inc. | MOD |
| May 20, 2025 | K242485 | EveryWare Breas Medical AB, SE | MOD |
| Feb 17, 2017 | K161411 | Care Cycle Connect Application Respironics, Inc. | MOD |
| Aug 14, 2009 | K091461 | BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE Cardiopulmonary Corp. | MOD |
| Dec 23, 2005 | K052751 | VENTLINK SYSTEM Mediserve Information Systems, Inc. | MOD |
| Oct 13, 2005 | K052244 | IISIS, VERSION 1.0 Innovision Medical Technologies, LLC | MOD |
| Jun 3, 2004 | K040712 | AIR SAFETY HEPA, MODEL 3500 Air Safety, Ltd. | MOD |
| May 6, 2003 | K022062 | IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00 Impact Instrumentation, Inc. | MOD |
| Oct 30, 2002 | K010401 | TRI-PLEX ADAPTER The Medical Device Group, Inc. | MOD |
| Nov 6, 2001 | K011861 | BERNOULLI VENTILATOR MANAGEMENT SYSTEM Cardiopulmonary Corp. | MOD |
| Dec 16, 1996 | K963633 | VENTNET; CENTRAL MONITORING STATION Puritan Bennett Corp. | MOD |
| Jul 3, 1995 | K935788 | BICORE SMARTCATH INTRATRACHEAL CATHETER Bicore Monitoring Systems | MOD |
| Jun 27, 1995 | K936156 | VENTILATION MECHANICS MONITOR MODEL VMM-100 Smith Industries Medical Systems (Sims) | MOD |
| Mar 7, 1995 | K940739 | NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR Newport Medical Instruments, Inc. | MOD |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.