Cleared Traditional

SPIROMETER MODEL NPB-500 (K980441) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K980441 · Nellcor Puritan Bennett, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
85d
Days
Class 2
Risk

K980441 is an FDA 510(k) clearance for the SPIROMETER MODEL NPB-500. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Nellcor Puritan Bennett, Inc. (Lenexa, US). The FDA issued a Cleared decision on April 30, 1998 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nellcor Puritan Bennett, Inc. devices

Submission Details

510(k) Number K980441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1998
Decision Date April 30, 1998
Days to Decision 85 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 140d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 21
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K980441.
Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
K191013 · Welch Allyn, Inc. · Sep 2019
ComPAS2 (Computerized Pulmonary Analysis System)
K190568 · Morgan Scientific, Inc. · Jun 2019
Pulmonx Chartis Tablet Console
K180011 · Pulmonx Corporation · Jul 2018
BREATH METER
K810437 · Fred Sammons, Inc. · May 1981