Cleared Traditional

K790224 - PADIATRY PACK & SHEET WITH FABRIC 450

K790224 is an FDA 510(k) clearance for PADIATRY PACK & SHEET WITH FABRIC 450, 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 14-day FDA review.

K790224 · Surgikos, Inc. · General Hospital
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Feb 1979
Decision
14d
Days
Class 2
Risk

K790224 is an FDA 510(k) clearance for the PADIATRY PACK & SHEET WITH FABRIC 450. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Surgikos, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 16, 1979 after a review of 14 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 - K790224

510(k) Number K790224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1979
Decision Date February 16, 1979
Days to Decision 14 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
115d faster than avg
Panel avg: 129d · This submission: 14d
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 228
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K790224.
IMPERVIOUS STERILE STOCKINETTE
K790634 · Anago, Inc. · Apr 1979
DELTA-NET
K790341 · Johnson & Johnson Professionals, Inc. · Apr 1979
LIMB SHEET WITH FABRIC 450
K790225 · Surgikos, Inc. · Feb 1979
STOCKINETTE, DISPOSABLESURGICAL
K782091 · Anago, Inc. · Jan 1979
STOCKINETTE
K781944 · Kimberly-Clark Corp. · Dec 1978
U-DRAPE, BOUNDARY
K781172 · Procter & Gamble Mfg. Co. · Aug 1978