Cleared Traditional

K213169 - BPAP System (FDA 510(k) Clearance)

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

K213169 · BMC Medical Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
433d
Days
Class 2
Risk

K213169 is an FDA 510(k) clearance for the BPAP System. Classified as Ventilator, Continuous, Non-life-supporting (product code MNS), Class II - Special Controls.

Submitted by BMC Medical Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on December 5, 2022 after a review of 433 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all BMC Medical Co., Ltd. devices

Submission Details

510(k) Number K213169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2021
Decision Date December 05, 2022
Days to Decision 433 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
294d slower than avg
Panel avg: 139d · This submission: 433d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MNS Ventilator, Continuous, Non-life-supporting
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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

Mid-Link Consulting Co, Ltd.
Diana Hong

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.