Cleared Traditional

K971336 - CAIRD TECHNOLOGY SPIROMETER

K971336 is an FDA 510(k) clearance for CAIRD TECHNOLOGY SPIROMETER, manufactured by Caird Technology. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 600-day FDA review.

K971336 · Caird Technology · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
600d
Days
Class 2
Risk

K971336 is an FDA 510(k) clearance for the CAIRD TECHNOLOGY SPIROMETER. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Caird Technology (Columbia, US). The FDA issued a Cleared decision on December 1, 1998 after a review of 600 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 Caird Technology devices

FDA 510(k) Submission Details - K971336

510(k) Number K971336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1997
Decision Date December 01, 1998
Days to Decision 600 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
460d slower than avg
Panel avg: 140d · This submission: 600d
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 K971336.
EMS PULMONARY FUNCTION TESTING FILTER
K013123 · Engineered Medical Systems · Mar 2002
SPIROVIT SP-2, PNEUMOCHECK II
K992823 · Schiller AG · May 2000
SPIROVIT, MODEL SP-250
K984031 · Schiller AG · Apr 1999
SPIROCARD
K973138 · Qrs Diagnostic, LLC · Oct 1998
SPIROBANK PORTABLE PC BASED SPIROMETER
K973456 · Futuremed America, Inc. · Jul 1998
SPIROMETER MODEL NPB-500
K980441 · Nellcor Puritan Bennett, Inc. · Apr 1998