Cleared Traditional

K872805 - NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY SYSTEM

K872805 is an FDA 510(k) clearance for NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY..., manufactured by Squibb-Novo, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K872805 · Squibb-Novo, Inc. · General Hospital
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Oct 1987
Decision
86d
Days
Class 2
Risk

K872805 is an FDA 510(k) clearance for the NOVOLINPEN DIAL-A-DOSE INSULIN DELIVERY SYSTEM. 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 October 9, 1987 after a review of 86 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.

View all Squibb-Novo, Inc. devices

FDA 510(k) Submission Details - K872805

510(k) Number K872805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1987
Decision Date October 09, 1987
Days to Decision 86 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
43d faster than avg
Panel avg: 129d · This submission: 86d
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 544
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K872805.
DISPOSABLE SYRINGE
K882335 · Baxter Healthcare Corp · Jun 1988
MEDSURG MYELOGRAM TRAY
K880693 · Medsurg Industries, Inc. · May 1988
ALLERGIST SYRINGES
K880894 · Abco Dealers, Inc. · Mar 1988
JMS NEEDLES AND JMS SYRINGES
K871965 · Jms Co., Ltd. · Sep 1987
SAFETY SYRINGE
K872820 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1987
LOOK SPRING-ASSIST SYRINGES
K872944 · Look, Inc. · Sep 1987