Cleared Traditional

K980960 - IN-CHECK INSPIRATORY FLOWMETER

K980960 is an FDA 510(k) clearance for IN-CHECK INSPIRATORY FLOWMETER, manufactured by Clement Clarke Intl., Ltd.. The device is a Class 2 Anesthesiology device with product code BZH cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K980960 · Clement Clarke Intl., Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
86d
Days
Class 2
Risk

K980960 is an FDA 510(k) clearance for the IN-CHECK INSPIRATORY FLOWMETER. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Clement Clarke Intl., Ltd. (Harlow, GB). The FDA issued a Cleared decision on June 10, 1998 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1860 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K980960

510(k) Number K980960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1998
Decision Date June 10, 1998
Days to Decision 86 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
54d faster than avg
Panel avg: 140d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZH Device Classification - Class 2, Special Controls

Product Code BZH Meter, Peak Flow, Spirometry
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1860
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 - BZH Meter, Peak Flow, Spirometry

All 67
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K980960.
AIRWATCH II ZONELESS
K982675 · Enact Health Management Systems · Oct 1998
AIRWATCH II ZONE
K982676 · Enact Health Management Systems · Oct 1998
WHISTLE WATCH
K980550 · Harwill Medical (Pty) , Ltd. · Aug 1998
PEAK FLOW METER MINIMAX
K980443 · The D&T, Inc. · Apr 1998
MINI-BELL PEAK FLOW METER/LOW RANGE MODEL PEAK FLOW METER
K961779 · Avion Medical Products, Inc. · Jun 1997
PEAK FLOW METER
K970507 · Intl. Medical, Inc. · Jun 1997