SOLA 700,SOLA 500, SOLA 300— 510(k) K010724

Clearance details

Applicant

Drager Medizintechnik GmbH

Product code

Code FTD

Device class

Class 2

Regulation

21 CFR 878.4580

Advisory panel

General, Plastic Surgery

Date received

2001-03-12

Decision date

2001-06-07

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Telford, PA, US

• K133425 — SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT2013-12-05
• K130513 — VOLISTA 400; VOLISTA 6002013-05-08
• K123776 — POLARIS 100/2002013-03-08
• K111020 — ATRICURE DISSECTOR2011-06-09
• K100234 — HM-LAMP II2010-07-08

• K023289 — OPTION NIV, MODEL 8414115, UPGRADE KIT NIV, MODEL 84140722003-01-15
• K010793 — OXYLOG 1000, MODEL 2M868402001-12-20
• K012177 — VENTVIEW, MODEL 84140952001-09-04
• K003068 — SAVINA2001-06-25
• K010093 — NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 4742001-06-14

Malfunction

767

Total

767

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1850-2014 — Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model numbers YG19051 and YG19262.Class II·Terminated·Steris Corporation·20140404

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K010724.