Cleared Traditional

K870572 - ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORAC...

K870572 is an FDA 510(k) clearance for ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORAC..., manufactured by Arrow Intl., Inc.. The device is a Class 2 General Hospital device with product code JOL cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K870572 · Arrow Intl., Inc. · General Hospital
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May 1987
Decision
105d
Days
Class 2
Risk

K870572 is an FDA 510(k) clearance for the ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on May 26, 1987 after a review of 105 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K870572

510(k) Number K870572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1987
Decision Date May 26, 1987
Days to Decision 105 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
24d faster than avg
Panel avg: 129d · This submission: 105d
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 36
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K870572.
URESIL THORA-FLO THORACENTESIS PROCEDURE KIT
K872948 · Uresil Corp. · Nov 1987
DEKNATEL THORACIC CATHETER
K873517 · Deknatel, Inc. · Nov 1987
DEKNATEL TROCAR CATHETER
K873525 · Deknatel, Inc. · Nov 1987
'EXMOOR' ZOELLNER SUCKER ENDS
K864937 · Exmoor Plastics , Ltd. · Mar 1987
DEKNATEL THORACIC CATHETER
K852041 · Pfizer, Inc. · Jun 1985
IMPACT TURBO CATH
K851611 · Impact Instrumentation, Inc. · Jun 1985