Cleared Traditional

Peak.me (K180487) - FDA 510(k) Clearance

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

K180487 · Breathe Me, Ltd. · Anesthesiology device
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Oct 2018
Decision
245d
Days
Class 2
Risk

K180487 is an FDA 510(k) clearance for the Peak.me. Classified as Meter, Peak Flow, Spirometry (product code BZH), Class II - Special Controls.

Submitted by Breathe Me, Ltd. (Ra'Anana, IL). The FDA issued a Cleared decision on October 26, 2018 after a review of 245 days - an extended review 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: 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 Breathe Me, Ltd. devices

Submission Details

510(k) Number K180487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2018
Decision Date October 26, 2018
Days to Decision 245 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
105d slower than avg
Panel avg: 140d · This submission: 245d
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 Consultant

Qsite
Yoram Levy

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BZH Meter, Peak Flow, Spirometry

All 11
Devices cleared under the same product code (BZH) and FDA review panel - the closest regulatory comparables to K180487.
Safey Peak Flow Meter
K200832 · Safey Medical Devices Pvt, Ltd. · Jul 2020
Aluna
K193311 · Knox Medical Diagnostics, Inc. · Mar 2020
Smart Peak Flow Meter
K191239 · Guangzhou Homesun Medical Technology Co., Ltd. · Dec 2019
Smart One
K181666 · Mir Medical International Research · Aug 2018
Besmed Peak Flow Meter
K172804 · Besmed Health Business Corp · Jan 2018