510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991160Substantially Equivalent

Astotherm Plus, Astotubes, Astoline

Stihler Electronic GmbH, Sound Beach NY / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K991160 is the FDA 510(k) clearance record for ASTOTHERM PLUS, ASTOTUBES, ASTOLINE, a class II device, cleared for Stihler Electronic GmbH on under FDA product code BSB (Warmer, Blood, Non-Electromagnetic Radiation). FDA records list 7 510(k) clearances for Stihler Electronic GmbH, from to . As of , FDA records show no recalls naming K991160.

Clearance record

Decision date
Received
(148 days to decision)
Product code
BSB Warmer, Blood, Non-Electromagnetic Radiation
Regulation
21 CFR 864.9205
Device class
Class II
Review panel
Hematology
Applicant
Stihler Electronic GmbH 30 Northport Rd., Sound Beach NY
510(k) summary
Statement
Third party review
No

Clearances, product code BSB

Trailing 12 months

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

FDA records show no clearances under product code BSB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BSB, 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