Cleared Traditional

K851244 - GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO

K851244 is an FDA 510(k) clearance for GRECO-HARVEY SURFACTANT BONDED CATH FOR..., manufactured by Cook, Inc.. The device is a Class 2 General Hospital device with product code KDQ cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K851244 · Cook, Inc. · General Hospital
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Nov 1985
Decision
266d
Days
Class 2
Risk

K851244 is an FDA 510(k) clearance for the GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO. Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by Cook, Inc. (New Brunswick, US). The FDA issued a Cleared decision on November 19, 1985 after a review of 266 days - an extended review 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: 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 Cook, Inc. devices

FDA 510(k) Submission Details - K851244

510(k) Number K851244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1985
Decision Date November 19, 1985
Days to Decision 266 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
137d slower than avg
Panel avg: 129d · This submission: 266d
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 35
Devices cleared under the same product code (KDQ) and FDA review panel - the closest regulatory comparables to K851244.
FILTERED VACUUM SAFETY TRAP BOTTLE
K855074 · Boehringer Laboratories · Mar 1986
COMPACT 2000 WATER SEAL CHEST DRAINAGE UNIT
K860023 · Atrium Medical Corp. · Jan 1986
BARD PARKER THORACIC VENT
K854634 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 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