Cleared Traditional

K780844 - BARRIER OBSTETRICAL PACK FABRIC 450

K780844 is an FDA 510(k) clearance for BARRIER OBSTETRICAL PACK 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 84-day FDA review.

K780844 · Surgikos, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1978
Decision
84d
Days
Class 2
Risk

K780844 is an FDA 510(k) clearance for the BARRIER OBSTETRICAL PACK 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 August 14, 1978 after a review of 84 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 - K780844

510(k) Number K780844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1978
Decision Date August 14, 1978
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
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 K780844.
BARRIER MEDIUM SHEET 450
K780841 · Surgikos, Inc. · Aug 1978
BARRIER BASIC PACK FABRIC 450
K780842 · Surgikos, Inc. · Aug 1978
BARRIER ABDOMINAL PACK FABRIC 450
K780843 · Surgikos, Inc. · Aug 1978
OP-SITE ADHESIVE DRAPES
K780853 · Acme United Corp. · Aug 1978
BARRIER GYNECOLOGY PACK FABRIC 450
K780856 · Surgikos, Inc. · Aug 1978
DRAPING MATERIAL, COLBALT 60 STERILE
K780846 · Kimberly-Clark Corp. · Jun 1978