Cleared Traditional

Safey Peak Flow Meter (K200832) - FDA 510(k) Clearance

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

K200832 · Safey Medical Devices Pvt, Ltd. · Anesthesiology device
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Jul 2020
Decision
122d
Days
Class 2
Risk

K200832 is an FDA 510(k) clearance for the Safey Peak Flow Meter. Classified as Meter, Peak Flow, Spirometry (product code BZH), 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 122 days - within the typical 510(k) review window.

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: 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

Submission Details

510(k) Number K200832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2020
Decision Date July 30, 2020
Days to Decision 122 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
17d faster than avg
Panel avg: 139d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 79
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K200832.
Peak Flow Meter (PF-10(BR-PEF231))
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Aluna 2
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Electronic Peak Flow Meter
K230423 · Taian Dalu Medical Instrument Co., Ltd. · Feb 2024
TD-7301 Peak Flow meter
K222810 · Gostar Co., Ltd. · Dec 2023
Peak flow meter
K203196 · Shanghai Sonmol Medical Equipment Co., Ltd. · May 2021