Cleared Traditional

SURG-O-PAK, GOWNS, SHEETS, AND TOWELS (K780627) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K780627 · Convertors · General Hospital
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Jul 1979
Decision
453d
Days
Class 2
Risk

K780627 is an FDA 510(k) clearance for the SURG-O-PAK, GOWNS, SHEETS, AND TOWELS. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Convertors (Mchenry, US). The FDA issued a Cleared decision on July 11, 1979 after a review of 453 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Convertors devices

Submission Details

510(k) Number K780627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1978
Decision Date July 11, 1979
Days to Decision 453 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
324d slower than avg
Panel avg: 129d · This submission: 453d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 23
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K780627.
LASER RESISTANT DRAPE
K873141 · Baxter Healthcare Corp · Oct 1987
OPSITE SPECIALITY DRAPES
K872757 · Smith & Nephew, Inc. · Jul 1987
3M GERMICIDAL SURGICAL INCISE DRAPE
K801550 · 3M Company · Sep 1981
ACCU-SORB STERILE STOCKINETTES
K791070 · Medline Industries, Inc. · Jun 1979
DELTA-NET
K790341 · Johnson & Johnson Professionals, Inc. · Apr 1979
UNDER BOTTOCKS DRAPE
K760997 · C.R. Bard, Inc. · Mar 1977