510(k) Report

510(k) · Cleared

Recalled · Class II · 2014

Sola 700,Sola 500, Sola 300

K010724510(k) AbbreviatedCleared Jun 7, 200187-day reviewClass II21 CFR 878.4580Recalls 5

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Drager Medizintechnik GmbH · FTD Lamp, Surgical

Cleared on Jun 7, 2001 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 5 times.

Decided
Jun 7, 2001
Review
87 days
Class
Class II
Product code
FTD
Recalls
5
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared200020052010201520202025
  1. This deviceK010724 Sola 700,Sola 500, Sola 300Drager Medizintechnik GmbH · 2001
  2. Descendant · cites it directly · 0 of its ownK123776 Polaris 100/200Drager Medical GmbH · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K123776Polaris 100/200Drager Medical GmbH · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010724Sola 700,Sola 500, Sola 300Drager Medizintechnik GmbH2001—
+1K123776Polaris 100/200Drager Medical GmbH2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K010724, 2001–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K123776Polaris 100/200Drager Medical GmbH20130

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 4, 2014Class IIZ-1850-2014Device DesignPotential for the welded seam in affected monitor spring arms to crack and/or break.
Sep 11, 2009Not classifiedZ-0414-2010Device DesignDrger 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 surgical light broke as a result of a crack…
Aug 26, 2009Not classifiedZ-2212-2009Nonconforming Material/Componentwelded seam may fail
Jan 9, 2004Not classifiedZ-0358-04Otheradjustment screw may break due to material fatigue
Jan 9, 2004Not classifiedZ-0359-04Otheradjustment screw may break due to material fatigue

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K123776 (Drager Medical GmbH, 2013) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FTD devices

FTD Lamp, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FTD

3in 2013

2007: 12010: 22011: 12013: 3
2007high 3 (2013) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FTD

70in 2013

2013: 70 days median
2007high 70 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FTD

6in 2023

2007: 112009: 92010: 32016: 12023: 6
2007high 11 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FTD

81in 2025

2007: 72008: 102009: 222010: 212011: 302012: 262013: 292014: 292015: 452016: 182017: 102018: 162019: 802020: 1052021: 652022: 1362023: 2512024: 1442025: 81
2007high 251 (2023) · low 7 (2007)2025

MAUDE reports naming product code FTD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—117
20080—010
20090—922
20102—321
20111—030
20120—026
2013370029
20140—029
20150—045
20160—118
20170—010
20180—016
20190—080
20200—0105
20210—065
20220—0136
20230—6251
20240—0144
20250—081
20260—0—

More from Drager Medizintechnik GmbH

8 FDA decisions under this applicant name. See the company

  • K023289Option Niv, Model 8414115, Upgrade Kit Niv, Model 8414072Drager Medizintechnik GmbH · 2003
  • K010793Oxylog 1000, Model 2M86840Drager Medizintechnik GmbH · 2001
  • K012177Ventview, Model 8414095Drager Medizintechnik GmbH · 2001
  • K003068SavinaDrager Medizintechnik GmbH · 2001
  • K010093Non-Invasive Ventilation Niv Option, Model 84 14 474Drager Medizintechnik GmbH · 20013 recalls

Recent decisions in FTD

The FTD category page

  • K133425Scintillant Dual Bent Tip Surgical Light, Scintillant Dual Straight Tip Surgical LightEngineered Medical Solutions Co., LLC · 2013
  • K130513Volista 400; Volista 600Maquet S.A.S. · 201319 recalls
  • K123776Polaris 100/200Drager Medical GmbH · 2013
  • K111020Atricure DissectorAtriCure, Inc. · 2011
  • K100234HM-Lamp IIHillusa, Inc. · 2010

https://510kreport.com/device/K010724 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010724: Sola 700,Sola 500, Sola 300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010724

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026