# K010724: Sola 700,Sola 500, Sola 300

- Pathway: 510(k) (Abbreviated)
- Applicant: Drager Medizintechnik GmbH
- Decided: Jun 7, 2001 after 87 days
- Product code: FTD (Lamp, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K123776: Polaris 100/200 (2013), 0 descendants of its own

## Recalls of this device
- Apr 4, 2014 · Class II · Z-1850-2014: Potential for the welded seam in affected monitor spring arms to crack and/or break.
- Sep 11, 2009 · Not classified · Z-0414-2010: Drger Medical AG & Co., KGaA informed STERIS Corporation that they received (4) reported international cases where a welded seam at the joint of the spring-loaded arm of the Drger SOLA 500/700 surgica
- Aug 26, 2009 · Not classified · Z-2212-2009: welded seam may fail
- Jan 9, 2004 · Not classified · Z-0358-04: adjustment screw may break due to material fatigue
- Jan 9, 2004 · Not classified · Z-0359-04: adjustment screw may break due to material fatigue

Source page: https://510kreport.com/device/K010724
Methodology: https://510kreport.com/methodology