Cleared Traditional

COLORLESS DISPOSIBLE PLASTIC SYRINGES (K813157) - FDA 510(k) Clearance

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

K813157 · Sam Joo Industrial Co., Ltd. · General Hospital
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Apr 1982
Decision
159d
Days
Class 2
Risk

K813157 is an FDA 510(k) clearance for the COLORLESS DISPOSIBLE PLASTIC SYRINGES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Sam Joo Industrial Co., Ltd. (Mchenry, US). The FDA issued a Cleared decision on April 14, 1982 after a review of 159 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 Sam Joo Industrial Co., Ltd. devices

Submission Details

510(k) Number K813157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1981
Decision Date April 14, 1982
Days to Decision 159 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
30d slower than avg
Panel avg: 129d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 240
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K813157.
DIRECTOR
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U-100 INSULIN SYRINGE
K822083 · Terumo Medical Corp. · Aug 1982
MONOJET 520 20CC SYRINGES W/NEEDLES
K822029 · Sherwood Medical Co. · Jul 1982
MONOJECT 512 SYRINGES W/WO NEEDLES
K820716 · Sherwood Medical Co. · Apr 1982
MONOJECT M560 60CC SYRINGES
K813480 · Sherwood Medical Co. · Jan 1982
20CC GLASS CONTROL SYRINGE
K813175 · Abco Dealers, Inc. · Nov 1981