Cleared Traditional

K972614 - TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODEL 605

K972614 is an FDA 510(k) clearance for TWISTER OXYGEN CONCENTRATOR MODEL 600, manufactured by Healthdyne Technologies, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K972614 · Healthdyne Technologies, Inc. · Anesthesiology device
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Jan 1998
Decision
190d
Days
Class 2
Risk

K972614 is an FDA 510(k) clearance for the TWISTER OXYGEN CONCENTRATOR MODEL 600, TWISTER OXYGEN CONCENTRATOR W/OPI MODE.... Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Healthdyne Technologies, Inc. (Marietta, US). The FDA issued a Cleared decision on January 20, 1998 after a review of 190 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Healthdyne Technologies, Inc. devices

FDA 510(k) Submission Details - K972614

510(k) Number K972614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1997
Decision Date January 20, 1998
Days to Decision 190 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 140d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAW Device Classification - Class 2, Special Controls

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - CAW Generator, Oxygen, Portable

All 138
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K972614.
VENTURE IHO 100 HOME FILL COMPLETE HOME OXYGEN SYSTEM
K983627 · Invacare Corp. · Oct 1999
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MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM
K983777 · Invacare Corp. · Dec 1998
CHAD TOTAL O2 DELIVERY SYSTEM
K971889 · Chad Therapeutics, Inc. · Nov 1997
INNOSAN TRAVELAIR S PLUS PORTABLE OXYGEN CONCENTRATOR, CODE NO. M407001853 (WITH AC POWER SUPPLY ACCESSORY)
K971947 · Sim Italia S.R.L. · Oct 1997
OXLIFE EXCELL OXYGEN CONCENTRATORS
K971964 · Oxlife, Inc. · Aug 1997