Cleared Traditional

K983601 - DEMAND OXYGEN CONSERVING DEVICE

K983601 is an FDA 510(k) clearance for DEMAND OXYGEN CONSERVING DEVICE, manufactured by Medical Electronic Devices, Inc.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K983601 · Medical Electronic Devices, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
62d
Days
Class 2
Risk

K983601 is an FDA 510(k) clearance for the DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Medical Electronic Devices, Inc. (Torrance, US). The FDA issued a Cleared decision on December 15, 1998 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medical Electronic Devices, Inc. devices

FDA 510(k) Submission Details - K983601

510(k) Number K983601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1998
Decision Date December 15, 1998
Days to Decision 62 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 140d · This submission: 62d
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 20
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K983601.
PM 1800 CONSERVING DEVICE
K001412 · Precision Medical, Inc. · Mar 2001
VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
K002284 · Invacare Corp. · Oct 2000
PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)
K990678 · Salter Labs · May 1999
PULSE DOSE SERIES
K961126 · Devilbiss Health Care, Inc. · Oct 1996
MODEL IPD OXYGEN CONSERVING DEVICE
K953852 · Invacare Corp. · Nov 1995
MODIFIED DEMAND NASAL OXYGEN CANNULA
K892407 · Salter Labs · Jul 1989