Cleared Traditional

APIS (R), VERIS (TM) (K222143) - FDA 510(k) Clearance

K222143 · Sweetbio, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
450d
Days
-
Risk

K222143 is an FDA 510(k) clearance for the APIS (R), VERIS (TM). Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Sweetbio, Inc. (Memphis, US). The FDA issued a Cleared decision on October 13, 2023 after a review of 450 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. 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 General & Plastic Surgery submissions.

View all Sweetbio, Inc. devices

Submission Details

510(k) Number K222143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2022
Decision Date October 13, 2023
Days to Decision 450 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
335d slower than avg
Panel avg: 115d · This submission: 450d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Kapstone Medical
Carolyn Guthrie

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 - FRO Dressing, Wound, Drug

All 168
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