Cleared Traditional

K973138 - SPIROCARD

K973138 is an FDA 510(k) clearance for SPIROCARD, manufactured by Qrs Diagnostic, LLC. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 433-day FDA review.

K973138 · Qrs Diagnostic, LLC · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
433d
Days
Class 2
Risk

K973138 is an FDA 510(k) clearance for the SPIROCARD. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Qrs Diagnostic, LLC (Plymouth, US). The FDA issued a Cleared decision on October 28, 1998 after a review of 433 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Qrs Diagnostic, LLC devices

FDA 510(k) Submission Details - K973138

510(k) Number K973138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1997
Decision Date October 28, 1998
Days to Decision 433 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
293d slower than avg
Panel avg: 140d · This submission: 433d
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 K973138.
SPIROVIT SP-2, PNEUMOCHECK II
K992823 · Schiller AG · May 2000
SPIROVIT, MODEL SP-250
K984031 · Schiller AG · Apr 1999
CAIRD TECHNOLOGY SPIROMETER
K971336 · Caird Technology · Dec 1998
SPIROBANK PORTABLE PC BASED SPIROMETER
K973456 · Futuremed America, Inc. · Jul 1998
SPIROMETER MODEL NPB-500
K980441 · Nellcor Puritan Bennett, Inc. · Apr 1998
MICRODL DIARYCARD SPIROMETER
K965042 · Micro Direct, Inc. · Jun 1997