Cleared Traditional

K152597 - ProteXsure Safety Capsule System

K152597 is an FDA 510(k) clearance for ProteXsure Safety Capsule System, manufactured by Starcap Medical, LLC ( Dba Prism Medical & Design). The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K152597 · Starcap Medical, LLC ( Dba Prism Medical & Design) · General Hospital
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Jun 2016
Decision
271d
Days
Class 2
Risk

K152597 is an FDA 510(k) clearance for the ProteXsure Safety Capsule System. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Starcap Medical, LLC ( Dba Prism Medical & Design) (Parkland, US). The FDA issued a Cleared decision on June 8, 2016 after a review of 271 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K152597

510(k) Number K152597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2015
Decision Date June 08, 2016
Days to Decision 271 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 129d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 Consultant

Starcap Medical, LLC
Matt Hedlund

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 - FMI Needle, Hypodermic, Single Lumen

All 647
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K152597.
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K153388 · Guangzhou Improve Medical Instruments Co., Ltd. · Jun 2016
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K161170 · Becton, Dickinson and Company · May 2016
K152597 · ProteXsure Safety Capsule System
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