Cleared Traditional

K961252 - DSXL DIFFUSION SPIROMETER (FDA 510(k) Clearance)

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

K961252 · Inair , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
319d
Days
Class 2
Risk

K961252 is an FDA 510(k) clearance for the DSXL DIFFUSION SPIROMETER. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Inair , Ltd. (Delmar, US). The FDA issued a Cleared decision on February 14, 1997 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1890 - 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. Elevated predicate reliance profile. 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 Inair , Ltd. devices

Submission Details

510(k) Number K961252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1996
Decision Date February 14, 1997
Days to Decision 319 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
180d slower than avg
Panel avg: 139d · This submission: 319d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTY Calculator, Predicted Values, Pulmonary Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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 - BTY Calculator, Predicted Values, Pulmonary Function

All 62
Devices cleared under the same product code (BTY) and FDA review panel - the closest regulatory comparables to K961252.
Ascent Cardiorespiratory Diagnostic Software
K242809 · Medical Graphics Corporation · Oct 2024
SpiroSphere, SpiroSphereECG, CardioSphere
K223629 · Eresearchtechnology GmbH · May 2024
Pulmonary Function Tester, Model: A9
K231561 · Guangzhou Homesun Medical Technology Co., Ltd. · Feb 2024
Virtus Metabolic Monitor
K222982 · Virtus Technology Aps · Jun 2023
Model 9100 PFT/DICO
K221030 · Vitalograph (Ireland) , Ltd. · Jul 2022
MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
K202754 · Eresearchtechnology GmbH · Jan 2021