Cleared Traditional

R.R. AGHI HYPODERMIC SINGLE LUMEN NEEDLE (K852615) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 197
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K852615.
BLOOD COLLECTING NEEDLE AND HOLDERS
K880892 · Abco Dealers, Inc. · Apr 1988
ULTRA-VUE SPINAL TYPE BIOPSY NEEDLE
K862610 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1987
DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET
K861390 · Baxter Healthcare Corp · Jul 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
MONOJECT STERILE M400 PLASTIC&STERILE M401 ALUMINU
K854549 · Sherwood Medical Co. · Feb 1986