Cleared Traditional

K221702 - CompuFlo Epidural Computer Controlled A...

K221702 is an FDA 510(k) clearance for CompuFlo Epidural Computer Controlled A..., manufactured by Milestone Scientific, Inc.. The device is a Class 2 Anesthesiology device with product code FMF cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K221702 · Milestone Scientific, Inc. · Anesthesiology device
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Feb 2023
Decision
257d
Days
Class 2
Risk

K221702 is an FDA 510(k) clearance for the CompuFlo Epidural Computer Controlled Anesthesia System. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Milestone Scientific, Inc. (Roseland, US). The FDA issued a Cleared decision on February 25, 2023 after a review of 257 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 880.5860 - 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 Milestone Scientific, Inc. devices

FDA 510(k) Submission Details - K221702

510(k) Number K221702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2022
Decision Date February 25, 2023
Days to Decision 257 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
117d slower than avg
Panel avg: 140d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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

RQM+
Kevin Go

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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