Cleared Traditional

K851135 - SPIRO SCAN

K851135 is the FDA 510(k) clearance for SPIRO SCAN by Brentwood Instruments, Inc.. It is a Class 2 Anesthesiology device (product code BZG) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K851135 · Brentwood Instruments, Inc. · Anesthesiology device
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Jul 1985
Decision
102d
Days
Class 2
Risk

K851135 is an FDA 510(k) clearance for the SPIRO SCAN. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Brentwood Instruments, Inc. (Torrance, US). The FDA issued a Cleared decision on July 1, 1985 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - 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. Standard predicate reliance. 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 Brentwood Instruments, Inc. devices

Submission Details

510(k) Number K851135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1985
Decision Date July 01, 1985
Days to Decision 102 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 140d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZG Spirometer, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
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 - BZG Spirometer, Diagnostic

All 30
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K851135.
PNEUMOCHECK W/PRINTER/CHARGER AND ACCESSORIES
K895253 · Welch Allyn, Inc. · Nov 1989
PURITAN BENNETT PB900A DIAGNOSTIC SPIROMETER
K890522 · Puritan Bennett Corp. · Apr 1989
PB900 PB910 DIAGNOSTIC SPIROMETER
K852092 · Puritan Bennett Corp. · Jul 1985
SPIROMED 2
K851620 · Draeger Medical, Inc. · May 1985
BREATH METER
K810437 · Fred Sammons, Inc. · May 1981