Cleared Traditional

K893667 - SUCTION TIP

K893667 is an FDA 510(k) clearance for SUCTION TIP, manufactured by Thomson & Shelton Instrumentation Co, Inc.. The device is a Class 2 General Hospital device with product code JOL cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K893667 · Thomson & Shelton Instrumentation Co, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1989
Decision
98d
Days
Class 2
Risk

K893667 is an FDA 510(k) clearance for the SUCTION TIP. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Thomson & Shelton Instrumentation Co, Inc. (Rockwall, US). The FDA issued a Cleared decision on August 21, 1989 after a review of 98 days - within the typical 510(k) review window.

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 Thomson & Shelton Instrumentation Co, Inc. devices

FDA 510(k) Submission Details - K893667

510(k) Number K893667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1989
Decision Date August 21, 1989
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
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 53
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K893667.
THOROCENTESIS KIT
K910963 · Megadyne Medical Products, Inc. · Jun 1991
CURITY THORACENTESIS TRAY
K903569 · Kendall Healthcare Products Co. Div.Of Tyco Health · Sep 1990
KLEEN TEST BASIN SET
K890039 · Kleen Test Products · Oct 1989
LAPAROSCOPIC SUCTION PROBE
K893527 · Dexide, Inc. · Jul 1989
ARROW PNEUMOTHORAX KIT, AK-01500
K883905 · Arrow Intl., Inc. · Jan 1989
URESIL THORA-FLO THORACENTESIS PROCEDURE KIT
K872948 · Uresil Corp. · Nov 1987