Cleared Traditional

K994230 - ULTICARE DISPOSABLE SYRINGE

K994230 is an FDA 510(k) clearance for ULTICARE DISPOSABLE SYRINGE, manufactured by Ultimed, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K994230 · Ultimed, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
99d
Days
Class 2
Risk

K994230 is an FDA 510(k) clearance for the ULTICARE DISPOSABLE SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Ultimed, Inc. (St. Paul, US). The FDA issued a Cleared decision on March 24, 2000 after a review of 99 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.

FDA 510(k) Submission Details - K994230

510(k) Number K994230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1999
Decision Date March 24, 2000
Days to Decision 99 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 129d · This submission: 99d
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 627
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K994230.
HARVEST TECHNOLOGIES DUAL LIQUID APPLICATOR, MODEL SK/S: HARVEST DUAL LIQUID APPLICATOR LK/2
K000456 · Harvest Technologies, LLC · Jun 2000
MULTI LUMEN SUCTION SYRINGE SPRAY DISPENSER
K000438 · Biosurgical Corp. · May 2000
HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01
K994023 · Haemacure Corp. · Apr 2000
PROFI DISPOSABLE SYRINGE, PROFI DISPOSABLE NEEDLE, DM JECT INSULIN SYRINGE
K993017 · Shinchang Medical Co., Ltd. · Feb 2000
VEIN ENTRY INDICATOR DEVICE (VEID)
K993995 · Vascular Technologies , Ltd. · Feb 2000
NIPRO INSULIN SYRINGE
K000144 · Nipro Medical Corp. · Feb 2000
K994230 · ULTICARE DISPOSABLE SYRINGE
Download PDF FDA Summary Ultimed, Inc.