Cleared Traditional

K892428 - COMBI-CAP

K892428 is an FDA 510(k) clearance for COMBI-CAP, manufactured by The Medi-Dose Group. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K892428 · The Medi-Dose Group · General Hospital
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Jul 1989
Decision
95d
Days
Class 2
Risk

K892428 is an FDA 510(k) clearance for the COMBI-CAP. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by The Medi-Dose Group (Feasterville, US). The FDA issued a Cleared decision on July 14, 1989 after a review of 95 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 The Medi-Dose Group devices

FDA 510(k) Submission Details - K892428

510(k) Number K892428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1989
Decision Date July 14, 1989
Days to Decision 95 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
34d faster than avg
Panel avg: 129d · This submission: 95d
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 K892428.
NEEDLE*LESS DRUG VIAL ADAPTER
K894177 · Baxter Healthcare Corp · Sep 1989
SYRINGE TIP ADAPTOR
K894217 · Acacia, Inc. · Sep 1989
MODEL #535 PACU STRETCHER/BED & #530 ED/TRAUMA STR
K894335 · Midmark Corp. · Sep 1989
DISPENSING PIN/CHEMOTHERAPY DISPENSING PIN
K890082 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1989
CONTROL SYRINGE
K884497 · Professional Medical Services · Dec 1988
SINGLE-FIL(TM) SYRINGE
K883955 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988