Cleared Traditional

K790341 - DELTA-NET

K790341 is an FDA 510(k) clearance for DELTA-NET, manufactured by Johnson & Johnson Professionals, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K790341 · Johnson & Johnson Professionals, Inc. · General Hospital
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Apr 1979
Decision
42d
Days
Class 2
Risk

K790341 is an FDA 510(k) clearance for the DELTA-NET. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on April 4, 1979 after a review of 42 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 Johnson & Johnson Professionals, Inc. devices

FDA 510(k) Submission Details - K790341

510(k) Number K790341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1979
Decision Date April 04, 1979
Days to Decision 42 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
87d faster than avg
Panel avg: 129d · This submission: 42d
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 168
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K790341.
KIMLON UNIVERSAL DRAPE
K790636 · Kimberly-Clark Corp. · May 1979
TREATED BARRIER INCISE DRAPE
K790431 · Surgikos, Inc. · May 1979
IMPERVIOUS STERILE STOCKINETTE
K790634 · Anago, Inc. · Apr 1979
LIMB SHEET WITH FABRIC 450
K790225 · Surgikos, Inc. · Feb 1979
PADIATRY PACK & SHEET WITH FABRIC 450
K790224 · Surgikos, Inc. · Feb 1979
STOCKINETTE, DISPOSABLESURGICAL
K782091 · Anago, Inc. · Jan 1979