Cleared Traditional

K884120 - TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC)

K884120 is an FDA 510(k) clearance for TYPE 9240 ECG/RESP SYST ATHENA (ADULT &..., manufactured by S & W Medico Teknik. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 655-day FDA review.

K884120 · S & W Medico Teknik · Anesthesiology device
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Jul 1990
Decision
655d
Days
Class 2
Risk

K884120 is an FDA 510(k) clearance for the TYPE 9240 ECG/RESP SYST ATHENA (ADULT & PEDIATIC). Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by S & W Medico Teknik (Denmark, DK). The FDA issued a Cleared decision on July 17, 1990 after a review of 655 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all S & W Medico Teknik devices

FDA 510(k) Submission Details - K884120

510(k) Number K884120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1988
Decision Date July 17, 1990
Days to Decision 655 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
515d slower than avg
Panel avg: 140d · This submission: 655d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZQ Device Classification - Class 2, Special Controls

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BZQ Monitor, Breathing Frequency

All 86
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K884120.
RESPIRATION/HEART RATE MONITOR MODEL 9500/9550
K903020 · Aequitron Medical, Inc. · Apr 1991
MODEL 900S APNEA/HEART MONITOR
K903287 · Healthdyne, Inc. · Aug 1990
R-BAND(TM) RESPIRATORY SENSOR
K900264 · Buckman Co., Inc. · Jul 1990
MODEL 9200 RESPIRATION/HEART RATE MONITOR
K901656 · Aequitron Medical, Inc. · Jul 1990
MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON
K902785 · Aequitron Medical, Inc. · Jul 1990
AR-800PA RESPIRATION MODULE
K891486 · Nihon Kohden America, Inc. · Oct 1989