Cleared Traditional

K193361 - ProCell Surgical Sponge-Blood Recovery ...

K193361 is the FDA 510(k) clearance for ProCell Surgical Sponge-Blood Recovery ... by Procell Surgical, Inc.. It is a Class 2 Cardiovascular device (product code CAC) cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K193361 · Procell Surgical, Inc. · Cardiovascular device
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Jun 2020
Decision
180d
Days
Class 2
Risk

K193361 is an FDA 510(k) clearance for the ProCell Surgical Sponge-Blood Recovery Unit. Classified as Apparatus, Autotransfusion (product code CAC), Class II - Special Controls.

Submitted by Procell Surgical, Inc. (Toronto, CA). The FDA issued a Cleared decision on June 1, 2020 after a review of 180 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 868.5830 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Procell Surgical, Inc. devices

Submission Details

510(k) Number K193361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2019
Decision Date June 01, 2020
Days to Decision 180 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 125d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAC Apparatus, Autotransfusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5830
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 Cardiovascular devices follow this clearance model.

Regulatory Consultant

MEDIcept, Inc.
Sharyn Orton

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 - CAC Apparatus, Autotransfusion

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