Cleared Traditional

K982943 - TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000

K982943 is an FDA 510(k) clearance for TRANSTRACHEAL DEMAND OXYGEN CONTROLLER ..., manufactured by Transtracheal Systems. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 325-day FDA review.

K982943 · Transtracheal Systems · Anesthesiology device
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Jul 1999
Decision
325d
Days
Class 2
Risk

K982943 is an FDA 510(k) clearance for the TRANSTRACHEAL DEMAND OXYGEN CONTROLLER MODEL DOC-3000. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Transtracheal Systems (Boulder, US). The FDA issued a Cleared decision on July 12, 1999 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Transtracheal Systems devices

FDA 510(k) Submission Details - K982943

510(k) Number K982943 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1998
Decision Date July 12, 1999
Days to Decision 325 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
185d slower than avg
Panel avg: 140d · This submission: 325d
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 38
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K982943.
VENTURE IDD OXYGEN CONSERVING DEVICE IDD 20EX AND 50EX
K002284 · Invacare Corp. · Oct 2000
IMPULSE SELECT
K001579 · Airsep Corp. · Aug 2000
CHAD THERAPEUTICS OXYMATIC MODEL 401
K000890 · Chad Therapeutics, Inc. · Jun 2000
PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)
K990678 · Salter Labs · May 1999
DEMAND OXYGEN CONSERVING DEVICE, DOCD, THE DOC
K983601 · Medical Electronic Devices, Inc. · Dec 1998
PULSED OXYGEN CONSERVING DEVICE, POCD
K983459 · Medical Electronic Devices, Inc. · Dec 1998