Cleared Traditional

NOVOPEN SYSTEM (INSULIN SYRINGE) (K861686) - FDA 510(k) Clearance

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

K861686 · Squibb-Novo, Inc. · General Hospital
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Jan 1987
Decision
264d
Days
Class 2
Risk

K861686 is an FDA 510(k) clearance for the NOVOPEN SYSTEM (INSULIN SYRINGE). Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Squibb-Novo, Inc. (Princeton, US). The FDA issued a Cleared decision on January 21, 1987 after a review of 264 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 Squibb-Novo, Inc. devices

Submission Details

510(k) Number K861686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1986
Decision Date January 21, 1987
Days to Decision 264 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
135d slower than avg
Panel avg: 129d · This submission: 264d
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 240
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K861686.
ALLERGIST SYRINGES
K880894 · Abco Dealers, Inc. · Mar 1988
SAFETY SYRINGE
K872820 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1987
MONOJECT PHARMACY TRAY
K860688 · Sherwood Medical Co. · Aug 1987
ADDITIVE EXTENSION SYRINGE
K853120 · Abbott Laboratories · Dec 1985
MONOJECT STERILE 3CC SYRINGES W/ & WO/ NEEDLES
K852544 · Sherwood Medical Co. · Jul 1985
MONOJECT STERILE 60CC SYRINGES
K852580 · Sherwood Medical Co. · Jul 1985