Cleared Traditional

K852503 - R.R. PRONTO SIRINGA

K852503 is an FDA 510(k) clearance for R.R. PRONTO SIRINGA, manufactured by Medical Hospital Equipment. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K852503 · Medical Hospital Equipment · General Hospital
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Nov 1985
Decision
154d
Days
Class 2
Risk

K852503 is an FDA 510(k) clearance for the R.R. PRONTO SIRINGA. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Medical Hospital Equipment (Chula Vista, US). The FDA issued a Cleared decision on November 13, 1985 after a review of 154 days - an extended review cycle.

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 Medical Hospital Equipment devices

FDA 510(k) Submission Details - K852503

510(k) Number K852503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1985
Decision Date November 13, 1985
Days to Decision 154 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
25d slower than avg
Panel avg: 129d · This submission: 154d
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 544
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K852503.
3 RING ATTACHMENT
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K861153 · Exel Intl. · Apr 1986
ADDITIVE EXTENSION SYRINGE
K853120 · Abbott Laboratories · Dec 1985
SPAN / AID SYRINGE
K854255 · Span-America Medical Systems, Inc. · Nov 1985
JMS LCC INSULIN SYRINGE
K853838 · Jms Co., Ltd. · Oct 1985
MONOJECT STERILE 3CC SYRINGES W/ & WO/ NEEDLES
K852544 · Sherwood Medical Co. · Jul 1985