Cleared Traditional

K970371 - FLOTEC OXYSAVRR (S)

K970371 is an FDA 510(k) clearance for FLOTEC OXYSAVRR (S), manufactured by Flotec, Inc.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K970371 · Flotec, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
160d
Days
Class 2
Risk

K970371 is an FDA 510(k) clearance for the FLOTEC OXYSAVRR (S). Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Flotec, Inc. (Indianapolis, US). The FDA issued a Cleared decision on July 10, 1997 after a review of 160 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 Flotec, Inc. devices

FDA 510(k) Submission Details - K970371

510(k) Number K970371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1997
Decision Date July 10, 1997
Days to Decision 160 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
20d slower than avg
Panel avg: 140d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFB Device Classification - Class 2, Special Controls

Product Code NFB Conserver, Oxygen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - NFB Conserver, Oxygen

All 35
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K970371.
CHAD THERAPEUTICS OXYMATIC MODEL 401
K000890 · Chad Therapeutics, Inc. · Jun 2000
PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)
K990678 · Salter Labs · May 1999
SANPO I
K964541 · Koike Medical Co. · Sep 1997
PULSE DOSE SERIES
K961126 · Devilbiss Health Care, Inc. · Oct 1996
AIRSEP IMPULSE
K962766 · Airsep Corp. · Oct 1996
MODEL IPD OXYGEN CONSERVING DEVICE
K953852 · Invacare Corp. · Nov 1995