Cleared Traditional

K862569 - HEAVY DUTY (HD) SUCTION UNITS (W/CANNULAS)

K862569 is an FDA 510(k) clearance for HEAVY DUTY (HD) SUCTION UNITS (W/CANNULAS), manufactured by Jedmed Instrument Co.. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K862569 · Jedmed Instrument Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1986
Decision
38d
Days
Class 2
Risk

K862569 is an FDA 510(k) clearance for the HEAVY DUTY (HD) SUCTION UNITS (W/CANNULAS). Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Jedmed Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on August 14, 1986 after a review of 38 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery 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 Jedmed Instrument Co. devices

FDA 510(k) Submission Details - K862569

510(k) Number K862569 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 07, 1986
Decision Date August 14, 1986
Days to Decision 38 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 115d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTA Device Classification - Class 2, Special Controls

Product Code BTA Pump, Portable, Aspiration (manual Or Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - BTA Pump, Portable, Aspiration (manual Or Powered)

All 106
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K862569.
AUTOVAC
K921107 · Life Support Products, Inc. · Sep 1992
VACPAC PORTABLE ASPIRATION SYSTEM
K910271 · Jedmed Instrument Co. · Mar 1991
BUNN MODEL 530 ASPIRATOR
K870094 · The John Bunn Co. · Mar 1987
PORTASPIR II
K851560 · Roseburg SA · Dec 1985
STORZ ASPIRATION MACHINE SAM 5000
K843644 · Storz Instrument Co. · Nov 1984
JACOBS HIGH VACUUM SUCTION UNIT 05-2570
K843693 · J. Sklar Mfg. Co., Inc. · Oct 1984