Cleared Traditional

K895853 - SECHRIST DISPOSABLE INFANT BREATHING CI...

K895853 is an FDA 510(k) clearance for SECHRIST DISPOSABLE INFANT BREATHING CI..., manufactured by Sechrist Industries, Inc.. The device is a Class 1 Anesthesiology device with product code BZO cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K895853 · Sechrist Industries, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1989
Decision
80d
Days
Class 1
Risk

K895853 is an FDA 510(k) clearance for the SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by Sechrist Industries, Inc. (Anaheim, US). The FDA issued a Cleared decision on December 22, 1989 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5975 - 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 Sechrist Industries, Inc. devices

FDA 510(k) Submission Details - K895853

510(k) Number K895853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1989
Decision Date December 22, 1989
Days to Decision 80 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 140d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

BZO Device Classification - Class 1, General Controls

Product Code BZO Set, Tubing And Support, Ventilator (w Harness)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5975
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 - BZO Set, Tubing And Support, Ventilator (w Harness)

All 30
Devices cleared under the same product code (BZO) and FDA review panel - the closest regulatory comparables to K895853.
DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED
K922479 · Intertech Resources, Inc. · Oct 1992
GAS SAMPLING KIT MODIFICATION
K921510 · Respiratory Support Products, Inc. · Jun 1992
UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION
K911328 · Intertech Resources, Inc. · Aug 1991
OXYGEN CONNECTOR AND OXYGEN DELIVERY TUBING
K890011 · Life Design Systems, Inc. · Mar 1989
BAXTER, PHARMASEAL PATIENT GAS SAMPLING LINES
K880637 · Baxter Healthcare Corp · Apr 1988
PORTABLE VENTILATOR PATIENT CIRCUIT
K873900 · Puritan Bennett Corp. · Oct 1987