Cleared Traditional

K852615 - R.R. AGHI HYPODERMIC SINGLE LUMEN NEEDLE

K852615 is an FDA 510(k) clearance for R.R. AGHI HYPODERMIC SINGLE LUMEN NEEDLE, manufactured by Medical Hospital Equipment. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K852615 · Medical Hospital Equipment · General Hospital
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Mar 1986
Decision
282d
Days
Class 2
Risk

K852615 is an FDA 510(k) clearance for the R.R. AGHI HYPODERMIC SINGLE LUMEN NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Medical Hospital Equipment (Chula Vista, US). The FDA issued a Cleared decision on March 21, 1986 after a review of 282 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Medical Hospital Equipment devices

FDA 510(k) Submission Details - K852615

510(k) Number K852615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1985
Decision Date March 21, 1986
Days to Decision 282 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
153d slower than avg
Panel avg: 129d · This submission: 282d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 529
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K852615.
ICU MEDICAL NEEDLE, LOPEZ NEEDLE
K860781 · Icu Medical, Inc. · May 1986
EXEL VACUUM BLOOD COLLECTING SYSTEM
K861152 · Exel Intl. · May 1986
DISPOSABLE NEEDLE COUNTER (20-720)
K861318 · Anago, Inc. · May 1986
BLOOD COLLECTING NEEDLE
K855248 · Churchill Corp. · Feb 1986
MONOJECT STERILE M200 ALUMINUM/M250 POLYPROPYLENE
K854547 · Sherwood Medical Co. · Feb 1986
MONOJECT STERILE M216 BLOOD COLLECTION NEEDLES
K854548 · Sherwood Medical Co. · Feb 1986