Cleared Traditional

K813075 - TRITEC DOC TM

K813075 is the FDA 510(k) clearance for TRITEC DOC TM by Tri-Tech, Inc.. It is a Class 2 Anesthesiology device (product code BZD) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K813075 · Tri-Tech, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1981
Decision
37d
Days
Class 2
Risk

K813075 is an FDA 510(k) clearance for the TRITEC DOC TM. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Tri-Tech, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 9, 1981 after a review of 37 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 Tri-Tech, Inc. devices

Submission Details

510(k) Number K813075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1981
Decision Date December 09, 1981
Days to Decision 37 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 140d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZD Ventilator, Non-continuous (respirator)
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 - BZD Ventilator, Non-continuous (respirator)

All 212
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K813075.
COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM
K910194 · Puritan Bennett Corp. · May 1991
RESPIRONICS BIPAP REMOTE CONTROL UNIT
K905540 · Respironics, Inc. · Jan 1991
DISPOSABLE VVC(VOLUME VENTILATOR CIRCUIT)
K852821 · Puritan Bennett Corp. · Jul 1985
ARGYLE CPAP NASAL CANNULA
K811409 · Sherwood Medical Co. · Jun 1981