Cleared Traditional

K851135 - SPIRO SCAN

K851135 is an FDA 510(k) clearance for SPIRO SCAN, manufactured by Brentwood Instruments, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K851135

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
Combination Product No
PCCP Authorized No
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.

BZG Device Classification - Class 2, Special Controls

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 69
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K851135.
PALL PULMONARY FUNCTION FILTER
K854062 · Pall Biomedical Products Co. · Nov 1985
PB900 PB910 DIAGNOSTIC SPIROMETER
K852092 · Puritan Bennett Corp. · Jul 1985
PULMONARY TEST SYSTEM FUDAC-30
K852307 · Futuremed Div. of Future Impex Corp. · Jul 1985
PNEUMOSCOPE
K852337 · Erich Jaeger, Inc. · Jul 1985
ST-460 SPIRO ANALYZER SPIROMETER
K852308 · Futuremed Div. of Future Impex Corp. · Jun 1985
SPIROMED 2
K851620 · Draeger Medical, Inc. · May 1985