Cleared Traditional

CAREJECT DISPOSABLE SYRINGE AND NEEDLE (K931472) - FDA 510(k) Clearance

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

K931472 · Carewell Mediproducts, Ltd. · General Hospital
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Feb 1994
Decision
335d
Days
Class 2
Risk

K931472 is an FDA 510(k) clearance for the CAREJECT DISPOSABLE SYRINGE AND NEEDLE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Carewell Mediproducts, Ltd. (New Delhi, IN). The FDA issued a Cleared decision on February 22, 1994 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Carewell Mediproducts, Ltd. devices

Submission Details

510(k) Number K931472 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1993
Decision Date February 22, 1994
Days to Decision 335 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
206d slower than avg
Panel avg: 129d · This submission: 335d
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 K931472.
1ML LUER-LOK SYRINGE
K941562 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994
BD MICRO FINE, ULTRA FINE, AND ALLERGY SYRINGE
K941657 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994
ADVANTAGE SYRINGE
K941545 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994
MONOJECT(R) 6 CC SAFETY SYRINGE
K924511 · Sherwood Medical Co. · Jul 1993
ARGYLE TURKEL SAFETY THORACENTESIS PROC. TRAY
K930847 · Sherwood Medical Co. · Jul 1993
BECTON DICKINSON DISPOS. SYRINGES PLUNGER TIP MOD.
K930321 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1993