510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010724Substantially Equivalent

Sola 700,Sola 500, Sola 300

Drager Medizintechnik GmbH, Telford PA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K010724 is the FDA 510(k) clearance record for SOLA 700,SOLA 500, SOLA 300, a class II device, cleared for Drager Medizintechnik GmbH on under FDA product code FTD (Lamp, Surgical). FDA records list 8 510(k) clearances for Drager Medizintechnik GmbH, from to . As of , FDA records show 5 recalls naming K010724.

Clearance record

Decision date
Received
(87 days to decision)
Product code
FTD Lamp, Surgical
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Drager Medizintechnik GmbH 3135 Quarry Rd., Telford PA
510(k) summary
Summary
Third party review
No

Clearances, product code FTD

Trailing 12 months

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

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