Cleared Traditional

PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET (K910693) - FDA 510(k) Clearance

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

K910693 · Baxter Healthcare Corp · General Hospital
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Oct 1991
Decision
240d
Days
Class 2
Risk

K910693 is an FDA 510(k) clearance for the PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Valencia, US). The FDA issued a Cleared decision on October 17, 1991 after a review of 240 days - an extended review 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: 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K910693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1991
Decision Date October 17, 1991
Days to Decision 240 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 129d · This submission: 240d
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 10
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K910693.
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
ARGYLE YANKAVER SUCTION TUBE W/CONTROL
K832027 · Sherwood Medical Co. · Aug 1983
ARGYLE THORACIC CATHETERS
K820718 · Sherwood Medical Co. · Apr 1982
ARGYLE UNIVERSAL POOLE SUCTION TUBE
K803187 · Sherwood Medical Co. · Jan 1981