Cleared Traditional

K911440 - RAPI-JECT(R) SYRINGE

K911440 is an FDA 510(k) clearance for RAPI-JECT SYRINGE, manufactured by David Bull Laboratories, USA, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K911440 · David Bull Laboratories, USA, Inc. · General Hospital
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Dec 1991
Decision
273d
Days
Class 2
Risk

K911440 is an FDA 510(k) clearance for the RAPI-JECT(R) SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by David Bull Laboratories, USA, Inc. (Scottsdale, US). The FDA issued a Cleared decision on December 30, 1991 after a review of 273 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 David Bull Laboratories, USA, Inc. devices

FDA 510(k) Submission Details - K911440

510(k) Number K911440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1991
Decision Date December 30, 1991
Days to Decision 273 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
144d slower than avg
Panel avg: 129d · This submission: 273d
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 535
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K911440.
IRRIGATING SYRINGE
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B-D INTERLINK SYRINGE CANNULA
K920422 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
BECTON DICKINSON SAFETY-LOK SYRINGE
K920321 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
DAVOL IMPLANT PORTS W/ATTACH HI PERF GROSHONG CATH
K913235 · Davol, Inc. · Oct 1991
B-D(TM) MICROFINE(TM) IV PEN INJECTOR CAT. #328204
K912330 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
JOHNSON & JOHNSON DUAL SYRINGE APPLICATOR
K902157 · Johnson & Johnson Medical, Inc. · Nov 1990