Cleared Traditional

K980078 - PENETREASE

K980078 is an FDA 510(k) clearance for PENETREASE, manufactured by P.T. Panca Pusaka Deli. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 281-day FDA review.

K980078 · P.T. Panca Pusaka Deli · General Hospital
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Oct 1998
Decision
281d
Days
Class 2
Risk

K980078 is an FDA 510(k) clearance for the PENETREASE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by P.T. Panca Pusaka Deli (Chester, US). The FDA issued a Cleared decision on October 16, 1998 after a review of 281 days - an extended review cycle.

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 P.T. Panca Pusaka Deli devices

FDA 510(k) Submission Details - K980078

510(k) Number K980078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1998
Decision Date October 16, 1998
Days to Decision 281 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
152d slower than avg
Panel avg: 129d · This submission: 281d
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 407
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K980078.
UNIFINE
K983994 · Owen Mumford USA, Inc. · Jan 1999
OWEN MUMFORD 3ML AUTOPEN
K983974 · Owen Mumford USA, Inc. · Dec 1998
DISETRONIC PEN
K982966 · Disetronic Medical Systems · Oct 1998
HUMAPEN AND HUMAPEN ERGO
K982842 · Eli Lilly and Co. · Sep 1998
LIGHT SABER ASPIRATION NEEDLE
K982018 · Minrad, Inc. · Aug 1998
STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)
K972728 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1998