Cleared Traditional

K812312 - STERILE WATER 4OZ.

K812312 is an FDA 510(k) clearance for STERILE WATER 4OZ., manufactured by Superior Plastic Products Corp.. The device is a Class 2 General Hospital device with product code JOL cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K812312 · Superior Plastic Products Corp. · General Hospital
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Nov 1981
Decision
88d
Days
Class 2
Risk

K812312 is an FDA 510(k) clearance for the STERILE WATER 4OZ.. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Superior Plastic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on November 13, 1981 after a review of 88 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Superior Plastic Products Corp. devices

FDA 510(k) Submission Details - K812312

510(k) Number K812312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1981
Decision Date November 13, 1981
Days to Decision 88 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
41d faster than avg
Panel avg: 129d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOL Device Classification - Class 2, Special Controls

Product Code JOL Catheter And Tip, Suction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 - JOL Catheter And Tip, Suction

All 52
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K812312.
SUCTION CATHETERS
K830942 · Medovations, Inc. · Apr 1983
METAL BACKED ACETABULAR COMPONENT
K821342 · Intermedics Orthopedics · May 1982
ARGYLE THORACIC CATHETERS
K820718 · Sherwood Medical Co. · Apr 1982
ARGYLE UNIVERSAL POOLE SUCTION TUBE
K803187 · Sherwood Medical Co. · Jan 1981
MACROVAC
K801127 · Progress Mankind Technology · May 1980
MICROVAC
K801134 · Progress Mankind Technology · May 1980