Cleared Traditional

K182548 - Accucuff Cuff Pressure Indicator

K182548 is an FDA 510(k) clearance for Accucuff Cuff Pressure Indicator, manufactured by Tianjin Medis Medical Device Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BSK cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K182548 · Tianjin Medis Medical Device Co., Ltd. · Anesthesiology device
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Jan 2019
Decision
130d
Days
Class 2
Risk

K182548 is an FDA 510(k) clearance for the Accucuff Cuff Pressure Indicator. Classified as Cuff, Tracheal Tube, Inflatable (product code BSK), Class II - Special Controls.

Submitted by Tianjin Medis Medical Device Co., Ltd. (Tainjin, CN). The FDA issued a Cleared decision on January 25, 2019 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5750 - 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 Tianjin Medis Medical Device Co., Ltd. devices

FDA 510(k) Submission Details - K182548

510(k) Number K182548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2018
Decision Date January 25, 2019
Days to Decision 130 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
10d faster than avg
Panel avg: 140d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSK Device Classification - Class 2, Special Controls

Product Code BSK Cuff, Tracheal Tube, Inflatable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5750
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.

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