Cleared Traditional

K831028 - TI-1000 TRANSPORT INCUBATOR

K831028 is an FDA 510(k) clearance for TI-1000 TRANSPORT INCUBATOR, manufactured by Narco Scientific. The device is a Class 2 General Hospital device with product code FPL cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K831028 · Narco Scientific · General Hospital
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May 1983
Decision
40d
Days
Class 2
Risk

K831028 is an FDA 510(k) clearance for the TI-1000 TRANSPORT INCUBATOR. Classified as Incubator, Neonatal Transport (product code FPL), Class II - Special Controls.

Submitted by Narco Scientific (Mchenry, US). The FDA issued a Cleared decision on May 9, 1983 after a review of 40 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Narco Scientific devices

FDA 510(k) Submission Details - K831028

510(k) Number K831028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1983
Decision Date May 09, 1983
Days to Decision 40 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 129d · This submission: 40d
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 K831028.
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
REVISED BATTERY CHARGER
K790689 · Vickers America Medical Corp. · May 1979
TRANSPORT INCUBATOR
K790551 · Narco Air-Shields · Apr 1979
TRANSPORT INCUBATOR
K780964 · Cavitron Corp. · Jul 1978