Cleared Traditional

K811549 - TIMETER PRODUCED SCHRADER OXYGEN ADAPTOR

K811549 is an FDA 510(k) clearance for TIMETER PRODUCED SCHRADER OXYGEN ADAPTOR, manufactured by Timeter Instrument Corp.. The device is a Class 1 Anesthesiology device with product code BYX cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K811549 · Timeter Instrument Corp. · Anesthesiology device
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Jun 1981
Decision
16d
Days
Class 1
Risk

K811549 is an FDA 510(k) clearance for the TIMETER PRODUCED SCHRADER OXYGEN ADAPTOR. Classified as Tubing, Pressure And Accessories (product code BYX), Class I - General Controls.

Submitted by Timeter Instrument Corp. (Mchenry, US). The FDA issued a Cleared decision on June 18, 1981 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5860 - 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 Timeter Instrument Corp. devices

FDA 510(k) Submission Details - K811549

510(k) Number K811549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1981
Decision Date June 18, 1981
Days to Decision 16 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 140d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

BYX Device Classification - Class 1, General Controls

Product Code BYX Tubing, Pressure And Accessories
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5860
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BYX Tubing, Pressure And Accessories

All 24
Devices cleared under the same product code (BYX) and FDA review panel - the closest regulatory comparables to K811549.
OXYMIZER FLOW RESTRICTOR
K841901 · Chad Therapeutics, Inc. · Jul 1984
OXYGEN CONNECTING TUBE
K830988 · Medovations, Inc. · May 1983
OHIO AIR ADAPTOR
K813234 · Timeter Instrument Corp. · Dec 1981
TIMETER PRODUCED CHEMETRON (NCG) AIR
K811550 · Timeter Instrument Corp. · Jun 1981
TIMETER PRODUCED OHIO OXYGEN ADAPTOR
K811551 · Timeter Instrument Corp. · Jun 1981
TIMETER PRODUCED PURRITAN BENNETT O2 ADP
K801514 · Timeter Instrument Corp. · Jul 1980