Cleared Traditional

K841949 - DOSE RELEASE OF STERILIZATION LOTS

K841949 is the FDA 510(k) clearance for DOSE RELEASE OF STERILIZATION LOTS by Medcare Disp Products, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K841949 · Medcare Disp Products, Inc. · General Hospital
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Sep 1984
Decision
114d
Days
Class 2
Risk

K841949 is an FDA 510(k) clearance for the DOSE RELEASE OF STERILIZATION LOTS. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Medcare Disp Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 5, 1984 after a review of 114 days - within the typical 510(k) review window.

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 Medcare Disp Products, Inc. devices

Submission Details

510(k) Number K841949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1984
Decision Date September 05, 1984
Days to Decision 114 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
15d faster than avg
Panel avg: 129d · This submission: 114d
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 303
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K841949.
MONOJECT STERILE 1/2 CC & 1CC SYRINGES W & W/O NEE
K851090 · Sherwood Medical Co. · Apr 1985
BLOOD GAS SAMPLER KIT
K850958 · Churchill Corp. · Apr 1985
SYRINGE W/NEEDLE COMBIN & SYRINGE ONLY
K844106 · Abco Dealers, Inc. · Jan 1985
FLUID REMOVAL ASSEMBLY
K840490 · Ackrad Laboratories · Apr 1984
HYPODERMIC SYRINGES & NEEDLES
K834548 · Cordis Corp. · Mar 1984
SYRINGE
K833399 · I M, Inc. · Jan 1984