Cleared Traditional

Solidence Multipockets (K191131) - FDA 510(k) Clearance

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

K191131 · Solidence Surgical Corporation · General Hospital
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Aug 2022
Decision
1192d
Days
Class 2
Risk

K191131 is an FDA 510(k) clearance for the Solidence Multipockets. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Solidence Surgical Corporation (San Fernando, US). The FDA issued a Cleared decision on August 3, 2022 after a review of 1192 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital 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 General Hospital submissions.

View all Solidence Surgical Corporation devices

Submission Details

510(k) Number K191131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2019
Decision Date August 03, 2022
Days to Decision 1192 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1063d slower than avg
Panel avg: 129d · This submission: 1192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 General Hospital devices follow this clearance model.

Regulatory Peers - FRG Wrap, Sterilization

All 96
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K191131.
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K214007 · Owens & Minor (O&M) Halyard, Inc. · Jul 2022
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CareGUARD Sterilization Wrap
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