Cleared Traditional

K932138 - SALINE FOR IRRIGATION

K932138 is the FDA 510(k) clearance for SALINE FOR IRRIGATION by Rantran, Inc.. It is a Class 2 General Hospital device (product code JOL) cleared through the Traditional 510(k) pathway after a 562-day FDA review.

K932138 · Rantran, Inc. · General Hospital
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Nov 1994
Decision
562d
Days
Class 2
Risk

K932138 is an FDA 510(k) clearance for the SALINE FOR IRRIGATION. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Rantran, Inc. (Ashland, US). The FDA issued a Cleared decision on November 4, 1994 after a review of 562 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Rantran, Inc. devices

Submission Details

510(k) Number K932138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1993
Decision Date November 04, 1994
Days to Decision 562 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
433d slower than avg
Panel avg: 129d · This submission: 562d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 16
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K932138.
ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER
K950201 · Sherwood Medical Co. · Dec 1995
THORACENTESIS CATHETER
K951524 · Baxter Healthcare Corp · Jul 1995
STERILE WATER
K943773 · Medline Industries, Inc. · Feb 1995
DISPOSABLE SUCTION PROBE
K942061 · United States Surgical, A Division of Tyco Healthc · May 1994
PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET
K910693 · Baxter Healthcare Corp · Oct 1991
ARROW PNEUMOTHORAX KIT, AK-01500
K883905 · Arrow Intl., Inc. · Jan 1989