Cleared Traditional

K851560 - PORTASPIR II

K851560 is an FDA 510(k) clearance for PORTASPIR II, manufactured by Roseburg SA. The device is a Class 2 General & Plastic Surgery device with product code BTA cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K851560 · Roseburg SA · General & Plastic Surgery device
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Dec 1985
Decision
241d
Days
Class 2
Risk

K851560 is an FDA 510(k) clearance for the PORTASPIR II. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Roseburg SA (Washington, US). The FDA issued a Cleared decision on December 13, 1985 after a review of 241 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Roseburg SA devices

FDA 510(k) Submission Details - K851560

510(k) Number K851560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1985
Decision Date December 13, 1985
Days to Decision 241 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
126d slower than avg
Panel avg: 115d · This submission: 241d
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 68
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K851560.
PM PUMP ASPIRATOR
K932494 · Precision Medical, Inc. · Oct 1993
VACPAC PORTABLE ASPIRATION SYSTEM
K910271 · Jedmed Instrument Co. · Mar 1991
HEAVY DUTY (HD) SUCTION UNITS (W/CANNULAS)
K862569 · Jedmed Instrument Co. · Aug 1986
STORZ ASPIRATION MACHINE SAM 5000
K843644 · Storz Instrument Co. · Nov 1984
BRONCHOSCOPE SUCTION UNIT
K841399 · Keymed, Inc. · Jul 1984
CONNECTING TUBES
K831007 · Medovations, Inc. · May 1983