Cleared Traditional

K915633 - MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA

K915633 is an FDA 510(k) clearance for MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM..., manufactured by S & W Medico Teknik. The device is a Class 2 General Hospital device with product code FLL cleared through the Traditional 510(k) pathway after a 609-day FDA review.

K915633 · S & W Medico Teknik · General Hospital
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Jun 1993
Decision
609d
Days
Class 2
Risk

K915633 is an FDA 510(k) clearance for the MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA. Classified as Continuous Measurement Thermometer (product code FLL), Class II - Special Controls.

Submitted by S & W Medico Teknik (Denmark, DK). The FDA issued a Cleared decision on June 29, 1993 after a review of 609 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2910 - 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: 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 General Hospital submissions.

View all S & W Medico Teknik devices

FDA 510(k) Submission Details - K915633

510(k) Number K915633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1991
Decision Date June 29, 1993
Days to Decision 609 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
480d slower than avg
Panel avg: 129d · This submission: 609d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLL Device Classification - Class 2, Special Controls

Product Code FLL Continuous Measurement Thermometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2910
Definition A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.
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 - FLL Continuous Measurement Thermometer

All 398
Devices cleared under the same product code (FLL) and FDA review panel - the closest regulatory comparables to K915633.
EXTRACORPOREAL TEMPERATURE SENSOR
K935603 · Smiths Industries Medical Systems, Inc. · Feb 1994
ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR
K933832 · Electromedics, Inc. · Jan 1994
R & D BATTERIES, INC. PART # 5003, 5198, 5253
K933642 · R & D Batteries, Inc. · Jan 1994
OMRON TYMPANIC THERMOMETER MC-500
K922344 · Omron Healthcare, Inc. · Jun 1993
BATTERY PACK #1014NC
K925674 · Portable Power Systems, Inc. · May 1993
BATTERY PACK #1015NC
K925675 · Portable Power Systems, Inc. · May 1993