Cleared Traditional

K844942 - PLURA-GARD CHEST DRAINAGE SYSTEM

K844942 is the FDA 510(k) clearance for PLURA-GARD CHEST DRAINAGE SYSTEM by Consolidated Medical Equipment, Inc.. It is a Class 2 General Hospital device (product code KDQ) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K844942 · Consolidated Medical Equipment, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1985
Decision
82d
Days
Class 2
Risk

K844942 is an FDA 510(k) clearance for the PLURA-GARD CHEST DRAINAGE SYSTEM. Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by Consolidated Medical Equipment, Inc. (Utica, US). The FDA issued a Cleared decision on March 12, 1985 after a review of 82 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 Consolidated Medical Equipment, Inc. devices

Submission Details

510(k) Number K844942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1984
Decision Date March 12, 1985
Days to Decision 82 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
47d faster than avg
Panel avg: 129d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 33
Devices cleared under the same product code (KDQ) and FDA review panel - the closest regulatory comparables to K844942.
GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO
K851244 · Cook, Inc. · Nov 1985
COMPACT 2000
K851892 · Atrium Medical Corp. · Jun 1985
ABCO SUCTION CANISTER
K851316 · Abco Dealers, Inc. · May 1985
THORAX-KLEX CHEST DRAINAGE UNIT
K830671 · C.R. Bard, Inc. · Mar 1983
PLEURAL DRAINAGE SYSTEM #PDS-4300
K812224 · Bentley Laboratories, Inc. · Sep 1981
VAC-RITE SUNCTION COLLECTION
K811192 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1981