Cleared Traditional

K852041 - DEKNATEL THORACIC CATHETER

K852041 is an FDA 510(k) clearance for DEKNATEL THORACIC CATHETER, manufactured by Pfizer, Inc.. The device is a Class 2 General Hospital device with product code JOL cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K852041 · Pfizer, Inc. · General Hospital
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Jun 1985
Decision
39d
Days
Class 2
Risk

K852041 is an FDA 510(k) clearance for the DEKNATEL THORACIC CATHETER. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Pfizer, Inc. (Ny, US). The FDA issued a Cleared decision on June 17, 1985 after a review of 39 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 Pfizer, Inc. devices

FDA 510(k) Submission Details - K852041

510(k) Number K852041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1985
Decision Date June 17, 1985
Days to Decision 39 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
90d faster than avg
Panel avg: 129d · This submission: 39d
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 49
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K852041.
DEKNATEL TROCAR CATHETER
K873525 · Deknatel, Inc. · Nov 1987
ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT
K870572 · Arrow Intl., Inc. · May 1987
'EXMOOR' ZOELLNER SUCKER ENDS
K864937 · Exmoor Plastics , Ltd. · Mar 1987
IMPACT TURBO CATH
K851611 · Impact Instrumentation, Inc. · Jun 1985
THORA-CATH TROCAR-TYPE CHEST DRAINAGE TUBE
K851385 · Gesco Intl., Inc. · May 1985
PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE-
K843469 · Zimmar Consulting , Ltd. · Nov 1984