Cleared Traditional

K211155 - Auto CPAP System

K211155 is an FDA 510(k) clearance for Auto CPAP System, manufactured by BMC Medical Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 324-day FDA review.

K211155 · BMC Medical Co., Ltd. · Anesthesiology device
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Mar 2022
Decision
324d
Days
Class 2
Risk

K211155 is an FDA 510(k) clearance for the Auto CPAP System. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by BMC Medical Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on March 9, 2022 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 BMC Medical Co., Ltd. devices

FDA 510(k) Submission Details - K211155

510(k) Number K211155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2021
Decision Date March 09, 2022
Days to Decision 324 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
184d slower than avg
Panel avg: 140d · This submission: 324d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 285
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K211155.
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Luna G3 BPAP System
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iQ 2 Nasal Mask, Phantom 2 Nasal Mask
K211274 · Sleepnet Corporation · Jan 2022
DreamWear Silicone Pillows Mask
K210844 · Respironics, Inc. · Aug 2021
Magneto Nasal Mask
K210386 · Respironics, Inc. · Jul 2021