Cleared Traditional

K980878 - PULMOTRACK,MODEL 1010

K980878 is an FDA 510(k) clearance for PULMOTRACK, manufactured by Karmel Medical Acoustic Technologies , Ltd.. The device is a Class 2 Anesthesiology device with product code BZM cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K980878 · Karmel Medical Acoustic Technologies , Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
294d
Days
Class 2
Risk

K980878 is an FDA 510(k) clearance for the PULMOTRACK,MODEL 1010. Classified as Calculator, Pulmonary Function Interpretor (diagnostic) (product code BZM), Class II - Special Controls.

Submitted by Karmel Medical Acoustic Technologies , Ltd. (Tirat Hacarmel, IL). The FDA issued a Cleared decision on December 28, 1998 after a review of 294 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1900 - 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 - K980878

510(k) Number K980878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1998
Decision Date December 28, 1998
Days to Decision 294 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 140d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZM Device Classification - Class 2, Special Controls

Product Code BZM Calculator, Pulmonary Function Interpretor (diagnostic)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1900
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 - BZM Calculator, Pulmonary Function Interpretor (diagnostic)

All 21
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K980878 · PULMOTRACK,MODEL 1010
Download PDF FDA Summary Karmel Medical Acoust…