Cleared Traditional

K790804 - PURGE LINE UNIT

K790804 is an FDA 510(k) clearance for PURGE LINE UNIT, manufactured by Surgikos, Inc.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K790804 · Surgikos, Inc. · Cardiovascular device
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May 1979
Decision
31d
Days
Class 2
Risk

K790804 is an FDA 510(k) clearance for the PURGE LINE UNIT. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Surgikos, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 25, 1979 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4290 - the FDA cardiovascular device oversight 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 Surgikos, Inc. devices

FDA 510(k) Submission Details - K790804

510(k) Number K790804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1979
Decision Date May 25, 1979
Days to Decision 31 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 125d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTL Device Classification - Class 2, Special Controls

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 92
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K790804.
3-WAY STOPCOCK W/MALE LOCKING LUER ADA.
K791914 · Abbott Laboratories · Oct 1979
ADAPTER-Y TYPE/CORONARY PERFUSION
K791498 · Dlp, Inc. · Aug 1979
STOPCOCK, THREE WAY
K791107 · Norton Performance Plastics Corp. · Jun 1979
ADAPTERS-Y-TYPE
K790563 · Dlp, Inc. · Apr 1979
ADAPTER-STRAIGHT
K790564 · Dlp, Inc. · Apr 1979
MODIFIED STERILE DISPOSABLE STOPCOCKS
K781579 · Cobe Laboratories, Inc. · Oct 1978