Cleared Traditional

K844853 - NIFA NON INVASIVE FLUTTER ASSEMBLY

K844853 is an FDA 510(k) clearance for NIFA NON INVASIVE FLUTTER ASSEMBLY, manufactured by Emergency Management Products, Inc.. The device is a Class 2 General Hospital device with product code KDQ cleared through the Traditional 510(k) pathway after a 363-day FDA review.

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

FDA 510(k) Submission Details - K844853

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.

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 K844853.
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
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