Cleared Traditional

K201002 - Safey Pocket Spirometer

K201002 is an FDA 510(k) clearance for Safey Pocket Spirometer, manufactured by Safey Medical Devices Pvt, Ltd.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K201002 · Safey Medical Devices Pvt, Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2020
Decision
105d
Days
Class 2
Risk

K201002 is an FDA 510(k) clearance for the Safey Pocket Spirometer. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Safey Medical Devices Pvt, Ltd. (Pune, IN). The FDA issued a Cleared decision on July 30, 2020 after a review of 105 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Safey Medical Devices Pvt, Ltd. devices

FDA 510(k) Submission Details - K201002

510(k) Number K201002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2020
Decision Date July 30, 2020
Days to Decision 105 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
35d faster than avg
Panel avg: 140d · This submission: 105d
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 122
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K201002.
Spirometer
K201493 · Mehow Innovative, Ltd. · Jun 2021
GoSpiro
K202837 · Monitored Therapeutics, Inc. · Dec 2020
Spirotrac
K201562 · Vitalograph (Ireland) , Ltd. · Oct 2020
Vitalograph Model 2120 In2itive eDiary
K200550 · Vitalograph (Ireland) , Ltd. · Jul 2020
Air Next
K183089 · Nuvoair AB · Jan 2020
Asthma Monitor AM3
K183479 · Eresearch Technology · Oct 2019