Cleared Traditional

K852443 - PHARMA-PLAST CLINIPAK

K852443 is an FDA 510(k) clearance for PHARMA-PLAST CLINIPAK, manufactured by Pharma-Plast USA, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K852443 · Pharma-Plast USA, Inc. · General Hospital
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Oct 1985
Decision
128d
Days
Class 2
Risk

K852443 is an FDA 510(k) clearance for the PHARMA-PLAST CLINIPAK. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Pharma-Plast USA, Inc. (Canada H3a 2n4, CA). The FDA issued a Cleared decision on October 16, 1985 after a review of 128 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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.

View all Pharma-Plast USA, Inc. devices

FDA 510(k) Submission Details - K852443

510(k) Number K852443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1985
Decision Date October 16, 1985
Days to Decision 128 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 129d · This submission: 128d
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 General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 522
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K852443.
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