Cleared Traditional

K870078 - ACCUPEN(R)

K870078 is an FDA 510(k) clearance for ACCUPEN, manufactured by Ulster Scientific, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K870078 · Ulster Scientific, Inc. · General Hospital
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Mar 1987
Decision
68d
Days
Class 2
Risk

K870078 is an FDA 510(k) clearance for the ACCUPEN(R). Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Ulster Scientific, Inc. (Highland, US). The FDA issued a Cleared decision on March 17, 1987 after a review of 68 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K870078

510(k) Number K870078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1987
Decision Date March 17, 1987
Days to Decision 68 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 129d · This submission: 68d
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 682
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K870078.
DISPOSABLE SYRINGE W/O NEEDLE
K870190 · Can-Am Surgical Corp. · Apr 1987
DISPOSABLE SYRINGE WITH NEEDLE
K870191 · Can-Am Surgical Corp. · Apr 1987
DISPOSABLE SYRINGE TUBERCULIN W/NEEDLE
K870192 · Can-Am Surgical Corp. · Apr 1987
E-Z JECT INSULIN SYRINGE
K870018 · Can-Am Surgical Corp. · Feb 1987
NOVOPEN SYSTEM (INSULIN SYRINGE)
K861686 · Squibb-Novo, Inc. · Jan 1987
BT HYPODERMIC SYRINGE
K864541 · Baron Technologies, Inc. · Jan 1987
K870078 · ACCUPEN(R)
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