Product code MOD— Anesthesiology
AIR SAFETY HEPA, MODEL 3500
- Classification name
- Accessory To Continuous Ventilator (Respirator)
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Total cleared
- 16
- First cleared
- Most recent
Market context for product code MOD
FDA has cleared devices under product code MOD between 1995 and 2026, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2025
- 2017
- 2009
- 2005
- 2004
- 2003
- 2002
- 2001
- 1996
- 1995
Top applicants under product code MOD
Recent clearances under product code MOD
- K261360 — EasyCare Tx 2
- K253807 — Valence InVent Xtend (CVG-4101-VXA)
- K260051 — CorVision® (91-205-Z0014)
- K242485 — EveryWare
- K161411 — Care Cycle Connect Application
- K091461 — BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE
- K052751 — VENTLINK SYSTEM
- K052244 — IISIS, VERSION 1.0
- K040712 — AIR SAFETY HEPA, MODEL 3500
- K022062 — IMPACT, UNIVERSAL SINGLE-LIMB, VENTILATOR CIRCUIT, MODEL 820-0099-00
- K010401 — TRI-PLEX ADAPTER
- K011861 — BERNOULLI VENTILATOR MANAGEMENT SYSTEM
- K963633 — VENTNET; CENTRAL MONITORING STATION
- K935788 — BICORE SMARTCATH INTRATRACHEAL CATHETER
- K936156 — VENTILATION MECHANICS MONITOR MODEL VMM-100
- K940739 — NEWPORT COMMUNICAT PROTOCOL INTERFACE ADAPTOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.