Cleared Traditional

K994211 - ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285

K994211 is an FDA 510(k) clearance for ACUCAM INTRAORAL CAMERA SHEATHS, manufactured by Dentsply Intl.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K994211 · Dentsply Intl. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
52d
Days
Class 2
Risk

K994211 is an FDA 510(k) clearance for the ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Dentsply Intl. (Des Plaines, US). The FDA issued a Cleared decision on February 4, 2000 after a review of 52 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 Dentsply Intl. devices

FDA 510(k) Submission Details - K994211

510(k) Number K994211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1999
Decision Date February 04, 2000
Days to Decision 52 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 129d · This submission: 52d
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 274
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K994211.
RESOLVE SURGICAL O.R. TOWELS
K001667 · Allegiance Healthcare Corp. · Jun 2000
VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR
K994199 · Custom Medical Products, Inc. · Jun 2000
CONVERTORS EQUIPMENT DRAPES
K000417 · Allegiance Healthcare Corp. · Mar 2000
CONVERTORS SURGICAL DRAPES
K993795 · Allegiance Healthcare Corp. · Jan 2000
BROADLINE OR TOWELS
K991667 · Broadline Medical Industries · Sep 1999
SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600
K990253 · Amba Medical , Ltd. · Sep 1999