Cleared Traditional

K970371 - FLOTEC OXYSAVRR (S)

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

K970371 · Flotec, Inc. · Anesthesiology device
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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

Submission Details

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
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.

Device Classification

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 9
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K970371.
Apogee
K200401 · Incoba Ltd D/B/A Dynaris · Nov 2020
EOCD
K041568 · Respironics, Inc. · Jul 2004
VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
K002284 · Invacare Corp. · Oct 2000
MODEL IPD OXYGEN CONSERVING DEVICE
K953852 · Invacare Corp. · Nov 1995
COMPANION MINI OXYGEN SAVER
K873901 · Puritan Bennett Corp. · Dec 1987
COMPANION OXYGEN SAVER
K863695 · Puritan Bennett Corp. · Oct 1986