Cleared Traditional

PENETREASE (K980078) - FDA 510(k) Clearance

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

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

Submission Details

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
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.

Device Classification

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 223
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K980078.
TERUMO U-100 INSULIN SYRING
K001474 · Terumo Medical Corp. · Jun 2000
VACLOK SYRINGE
K994253 · Merit Medical Systems, Inc. · Jan 2000
TERUMO U-100 INSULIN SYRINGE
K992802 · Terumo Medical Corp. · Sep 1999
STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)
K972728 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1998
BECTON DICKINSON SYRINGES
K980580 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998
B-D PEN ULTRA
K981797 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998