Cleared Traditional

K791032 - CARDIAC CATHETERIZATION SHEETS/PACKS

K791032 is an FDA 510(k) clearance for CARDIAC CATHETERIZATION SHEETS/PACKS, manufactured by Surgikos, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K791032 · Surgikos, Inc. · General Hospital
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Jun 1979
Decision
11d
Days
Class 2
Risk

K791032 is an FDA 510(k) clearance for the CARDIAC CATHETERIZATION SHEETS/PACKS. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Surgikos, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1979 after a review of 11 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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 Surgikos, Inc. devices

FDA 510(k) Submission Details - K791032

510(k) Number K791032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1979
Decision Date June 15, 1979
Days to Decision 11 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
118d faster than avg
Panel avg: 129d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKX Device Classification - Class 2, Special Controls

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 - KKX Drape, Surgical

All 261
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K791032.
BARRIER *450* TAPE STRIP
K791500 · Surgikos, Inc. · Aug 1979
SURGICAL FACE MASK
K790970 · Carapace, Inc. · Jul 1979
ACCU-SORB STERILE STOCKINETTES
K791070 · Medline Industries, Inc. · Jun 1979
KIMLON IMPERVIOUS STOCKINETTES
K790972 · Kimberly-Clark Corp. · Jun 1979
BARRIER SURGICAL DRAPES W/ DRISITE* W/MICROCIDE*
K790725 · Surgikos, Inc. · May 1979
KIMLON UNIVERSAL DRAPE
K790636 · Kimberly-Clark Corp. · May 1979