Cleared Traditional

K854065 - INFANT LIFE SUPPORT MODULE-20

K854065 is an FDA 510(k) clearance for INFANT LIFE SUPPORT MODULE-20, manufactured by Intl. Biomedics, Inc.. The device is a Class 2 General Hospital device with product code FPL cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K854065 · Intl. Biomedics, Inc. · General Hospital
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Jan 1986
Decision
104d
Days
Class 2
Risk

K854065 is an FDA 510(k) clearance for the INFANT LIFE SUPPORT MODULE-20. Classified as Incubator, Neonatal Transport (product code FPL), Class II - Special Controls.

Submitted by Intl. Biomedics, Inc. (Cleburne, US). The FDA issued a Cleared decision on January 16, 1986 after a review of 104 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5410 - 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 Intl. Biomedics, Inc. devices

FDA 510(k) Submission Details - K854065

510(k) Number K854065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1985
Decision Date January 16, 1986
Days to Decision 104 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
25d faster than avg
Panel avg: 129d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPL Device Classification - Class 2, Special Controls

Product Code FPL Incubator, Neonatal Transport
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5410
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 - FPL Incubator, Neonatal Transport

Devices cleared under the same product code (FPL) and FDA review panel - the closest regulatory comparables to K854065.
NxtGen Infant Transport Incubator
K220742 · International Biomedical · Jul 2022
GLOBE-TROTTER GT5400
K141565 · Draeger Medical Systems, Inc. · Sep 2014
MODEL TI500 ISOLETTE INFANT INCUBATOR
K941106 · Air-Shields, Inc. · Jun 1994
TI-1000 TRANSPORT INCUBATOR
K831028 · Narco Scientific · May 1983
TRANSPORT INCUBATOR
K780964 · Cavitron Corp. · Jul 1978