Cleared Traditional

K934215 - CONTAIN-OR

K934215 is the FDA 510(k) clearance for CONTAIN-OR by Dlp, Inc.. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K934215 · Dlp, Inc. · General Hospital
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Feb 1994
Decision
163d
Days
Class 2
Risk

K934215 is an FDA 510(k) clearance for the CONTAIN-OR. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on February 9, 1994 after a review of 163 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Dlp, Inc. devices

Submission Details

510(k) Number K934215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1993
Decision Date February 09, 1994
Days to Decision 163 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 129d · This submission: 163d
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 159
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K934215.
CONVERTORS OPTI-SORB DRAPE MATERIAL
K940702 · Baxter Healthcare Corp · Apr 1994
STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE
K924101 · Baxter Healthcare Corp · Apr 1994
STSTORZ DP5300 AND DP9502 STERILE DRAPES
K934445 · Storz Instrument Co. · Apr 1994
VARIOUS UTILITY/SURGICAL DRAPE, STERILE, DISPOSABL
K920346 · Trinity Laboratories, Inc. · Mar 1993
DRAPE UTILITY/SURGICAL STERILE DISPOSABLE
K920284 · Trinity Laboratories, Inc. · Oct 1992
E.R. SUTURE TRAY, STERILE, DISPOSABLE
K920518 · Trinity Laboratories, Inc. · Aug 1992