Cleared Traditional

K875027 - STAR CALC

K875027 is an FDA 510(k) clearance for STAR CALC, manufactured by Infrasonics Corp.. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K875027 · Infrasonics Corp. · Anesthesiology device
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Aug 1988
Decision
253d
Days
Class 2
Risk

K875027 is an FDA 510(k) clearance for the STAR CALC. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Infrasonics Corp. (San Diego, US). The FDA issued a Cleared decision on August 16, 1988 after a review of 253 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - 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 Infrasonics Corp. devices

FDA 510(k) Submission Details - K875027

510(k) Number K875027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1987
Decision Date August 16, 1988
Days to Decision 253 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
113d slower than avg
Panel avg: 140d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZC Device Classification - Class 2, Special Controls

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
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 - BZC Calculator, Pulmonary Function Data

All 28
Devices cleared under the same product code (BZC) and FDA review panel - the closest regulatory comparables to K875027.
MODIFIED STAR CALC
K895963 · Infrasonics Corp. · Mar 1990
OS-1 OCCLUSION SYSTEM - 1
K894839 · Medical, Inc. · Oct 1989
Q-PLEX 1
K881235 · Quinton, Inc. · Mar 1989
ALVEO-DIFFUSION TEST
K853443 · Erich Jaeger, Inc. · Feb 1986
OXYSCREEN
K843860 · Erich Jaeger, Inc. · Dec 1984
AW TEST
K843848 · Erich Jaeger, Inc. · Nov 1984