Cleared Traditional

K860927 - HD CRYSTALINE SUCTION TIP

K860927 is an FDA 510(k) clearance for HD CRYSTALINE SUCTION TIP, manufactured by Hospital Disposables, Inc.. The device is a Class 2 General Hospital device with product code JOL cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K860927 · Hospital Disposables, Inc. · General Hospital
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Mar 1986
Decision
16d
Days
Class 2
Risk

K860927 is an FDA 510(k) clearance for the HD CRYSTALINE SUCTION TIP. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Hospital Disposables, Inc. (Portland, US). The FDA issued a Cleared decision on March 27, 1986 after a review of 16 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 Hospital Disposables, Inc. devices

FDA 510(k) Submission Details - K860927

510(k) Number K860927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1986
Decision Date March 27, 1986
Days to Decision 16 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
113d faster than avg
Panel avg: 129d · This submission: 16d
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 K860927.
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
DEKNATEL THORACIC CATHETER
K852041 · Pfizer, Inc. · Jun 1985
IMPACT TURBO CATH
K851611 · Impact Instrumentation, Inc. · Jun 1985
THORA-CATH TROCAR-TYPE CHEST DRAINAGE TUBE
K851385 · Gesco Intl., Inc. · May 1985