Cleared Traditional

K951718 - HM-SPIRO

K951718 is an FDA 510(k) clearance for HM-SPIRO, manufactured by Hill-Med, Inc.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K951718 · Hill-Med, Inc. · Anesthesiology device
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Dec 1995
Decision
251d
Days
Class 2
Risk

K951718 is an FDA 510(k) clearance for the HM-SPIRO. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Hill-Med, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on December 20, 1995 after a review of 251 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K951718

510(k) Number K951718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1995
Decision Date December 20, 1995
Days to Decision 251 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 140d · This submission: 251d
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 196
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K951718.
ASTHMA MONITOR
K960078 · Erich Jaeger, Inc. · Sep 1996
SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO
K953948 · Futuremed America, Inc. · Jun 1996
FLOWMATE LTE
K954759 · Spirometrics Medical Equipment Co. · Apr 1996
MASTERSCREEN IOS
K954140 · Erich Jaeger GmbH & Co. KG · Dec 1995
DISCOVERY GRAPHIC PORTABLE SPIROMETER
K950223 · Futuremed America, Inc. · Nov 1995
DX1
K951227 · Creative Biomedics, Inc. · Aug 1995
K951718 · HM-SPIRO
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