Cleared Traditional

NIFA NON INVASIVE FLUTTER ASSEMBLY (K844853) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844853 · Emergency Management Products, Inc. · General Hospital
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Dec 1985
Decision
363d
Days
Class 2
Risk

K844853 is an FDA 510(k) clearance for the NIFA NON INVASIVE FLUTTER ASSEMBLY. Classified as Bottle, Collection, Vacuum (product code KDQ), Class II - Special Controls.

Submitted by Emergency Management Products, Inc. (Rockville, US). The FDA issued a Cleared decision on December 12, 1985 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Emergency Management Products, Inc. devices

Submission Details

510(k) Number K844853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1984
Decision Date December 12, 1985
Days to Decision 363 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
234d slower than avg
Panel avg: 129d · This submission: 363d
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 9
Devices cleared under the same product code (KDQ) and FDA review panel - the closest regulatory comparables to K844853.
BARD PARKER THORACIC VENT
K854634 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1985
GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO
K851244 · Cook, Inc. · Nov 1985
ABCO SUCTION CANISTER
K851316 · Abco Dealers, Inc. · May 1985
THORAX-KLEX CHEST DRAINAGE UNIT
K830671 · C.R. Bard, Inc. · Mar 1983
VAC-RITE SUNCTION COLLECTION
K811192 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1981
ARGYLE SUCTION CANISTER W/DISP. LINER
K802174 · Sherwood Medical Co. · Sep 1980