Cleared Traditional

VENTURE HOME FILL II, MODEL IOH 200

K003939 · Invacare Corp. · Anesthesiology
Mar 2001
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K003939 is an FDA 510(k) clearance for the VENTURE HOME FILL II, MODEL IOH 200, a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on March 21, 2001, 90 days after receiving the submission on December 21, 2000. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K003939 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 2000
Decision Date March 21, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAW — Generator, Oxygen, Portable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5440

Similar Devices — CAW Generator, Oxygen, Portable

All 282
Oxygen Concentrator (J10A)
K251534 · Foshan Kycare Medical Equipment Co., Ltd. · Dec 2025
Oxygen Concentrator-P2-O5E
K251764 · Qingdao Kingon Medical Science and Technology Co., Ltd. · Dec 2025
Portable oxygen concentrator (JLO-190P)
K252616 · Shenzhen Homed Medical Device Co., Ltd. · Dec 2025
V series portable oxygen concentrator (V5, V5C, V6, V6C)
K252268 · Shenzhen Harveymed Technology Co., Ltd. · Dec 2025
DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW)
K250805 · Devilbiss Healthcare, LLC · Dec 2025
Oxygen Concentrator (J5A)
K251607 · Foshan Kycare Medical Equipment Co., Ltd. · Nov 2025