Cleared Traditional

K841949 - DOSE RELEASE OF STERILIZATION LOTS

K841949 is an FDA 510(k) clearance for DOSE RELEASE OF STERILIZATION LOTS, manufactured by Medcare Disp Products, Inc.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K841949

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.

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 524
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K841949.
PHARMA-PLAST SYRINGE
K843471 · Zimmar Consulting , Ltd. · Oct 1984
PHARMA-PLAST SYRINGE WITH NEEDLE
K843472 · Zimmar Consulting , Ltd. · Oct 1984
PHARMA-PLAST INSULIN SYRINGE
K843473 · Zimmar Consulting , Ltd. · Oct 1984
FLUID REMOVAL ASSEMBLY
K840490 · Ackrad Laboratories · Apr 1984
HYPODERMIC SYRINGES & NEEDLES
K834548 · Cordis Corp. · Mar 1984
SYRINGE
K833399 · I M, Inc. · Jan 1984