Cleared Traditional

K781713 - ADAPTER

K781713 is an FDA 510(k) clearance for ADAPTER, manufactured by Novametrix Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K781713 · Novametrix Medical Systems, Inc. · Anesthesiology device
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Dec 1978
Decision
67d
Days
Class 2
Risk

K781713 is an FDA 510(k) clearance for the ADAPTER, C/D SUCTION. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Novametrix Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 12, 1978 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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 Novametrix Medical Systems, Inc. devices

FDA 510(k) Submission Details - K781713

510(k) Number K781713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1978
Decision Date December 12, 1978
Days to Decision 67 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
73d faster than avg
Panel avg: 140d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTR Device Classification - Class 2, Special Controls

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
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 - BTR Tube, Tracheal (w/wo Connector)

All 133
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K781713.
OXYGENERATOR NO. M-049
K790927 · Mem Medical, Inc. · May 1979
TUBE, ARMORED TRACHEAL
K790575 · National Patent Development Corp. · Apr 1979
ENDOTRACHEAL TUBE W/HOLDER & CONNECTOR
K790312 · Respiratory Support Products, Inc. · Feb 1979
FOME-CUF PVC
K780583 · Bivona Medical Technologies · May 1978
NORTON ENDOTRACHEAL
K771197 · V. Mueller O.V. Baxter Healthcare Corp. · Aug 1977