Cleared Traditional

K781234 - TUBES, LUKENS, TOMAS

K781234 is an FDA 510(k) clearance for TUBES, manufactured by Ludwig Medical, Inc.. The device is a Class 2 General Hospital device with product code KDQ cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K781234 · Ludwig Medical, Inc. · General Hospital
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Aug 1978
Decision
22d
Days
Class 2
Risk

K781234 is an FDA 510(k) clearance for the TUBES, LUKENS, TOMAS. Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by Ludwig Medical, Inc. (Walker, US). The FDA issued a Cleared decision on August 10, 1978 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - 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 Ludwig Medical, Inc. devices

FDA 510(k) Submission Details - K781234

510(k) Number K781234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1978
Decision Date August 10, 1978
Days to Decision 22 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
107d faster than avg
Panel avg: 129d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDQ Device Classification - Class 2, Special Controls

Product Code KDQ Bottle, Collection, Vacuum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 - KDQ Bottle, Collection, Vacuum

All 37
Devices cleared under the same product code (KDQ) and FDA review panel - the closest regulatory comparables to K781234.
THORA-DRAIN III PLASTIC DRAINAGE SYSTEM
K801221 · Chesebrough-Pond'S U.S.A. Co. · Jun 1980
CONPHAR SILICONE DRAINS-STERILE
K791254 · Conphar, Inc. · Aug 1979
SEP-T-VAC SUCTION CANNISTER W/ TUBING
K790379 · Sherwood Medical Co. · Apr 1979
SUCTION CANISTER
K781279 · Abco Dealers, Inc. · Aug 1978
AQUA-SEAL
K761202 · Respiratory Care, Inc. · Dec 1976