510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103527Substantially Equivalent

Aviator Transport Incubator with Masimo Pulseox, Aviator Transport Incubator with Nellcor Pulseox

International Biomedical, Ltd., Austin TX / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103527 is the FDA 510(k) clearance record for AVIATOR TRANSPORT INCUBATOR WITH MASIMO PULSEOX, AVIATOR TRANSPORT INCUBATOR WITH NELLCOR PULSEOX, a class II device, cleared for International Biomedical, Ltd. on under FDA product code FPL (Incubator, Neonatal Transport). FDA records list 17 510(k) clearances for International Biomedical, Ltd., from to . As of , FDA records show no recalls naming K103527.

Clearance record

Decision date
Received
(135 days to decision)
Product code
FPL Incubator, Neonatal Transport
Regulation
21 CFR 880.5410
Device class
Class II
Review panel
General Hospital
Applicant
International Biomedical, Ltd. 8508 Cross Park Dr., Austin TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FPL

Trailing 12 months

FDA records hold no clearances under product code FPL in the trailing twelve months.

FDA records show no clearances under product code FPL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FPL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260