510(k) · Cleared
ClearedZF 720
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Umbel Corporation · FSY Light, Surgical, Ceiling Mounted
Cleared on Jun 30, 2014 as substantially equivalent to K031068 (Stryker Endoscopy, 2003) and 1 other predicate after a 320-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- Jun 30, 2014
- Review
- 320 days
- Class
- Class II
- Product code
- FSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K904965 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK904965 Shampaine 1000 Series Angenieux AX-14 Duo,AX-4Smith & Nephew Equipment Group · 1991
- 2 generations backK040735 Alm X'ten (X10) Surgical Light SystemAlm S.A. · 2004 · Recalled
- 1 generation backK070442 Powerled Surgical Light SystemMaquet S.A. · 2007 · Recalled
- This deviceK132551 ZF 720Umbel Corporation · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904965 | Shampaine 1000 Series Angenieux AX-14 Duo,AX-4 | Smith & Nephew Equipment Group | 1991 | — |
| −2 | K040735 | Alm X'ten (X10) Surgical Light System | Alm S.A. | 2004 | 6 |
| −1 | K070442 | Powerled Surgical Light System | Maquet S.A. | 2007 | 3 |
| 0 (this device) | K132551 | ZF 720 | Umbel Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FSY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031068 | Stryker Visum Surgical Lighting SystemSummary page 1…Product Code: FSY Predicate Device Information Predicate Device]: Stryker Visum Surgical Lighting System 510(k) number: K031068 Predicate Device2: MAQUET POWERLED Surgical Light System 5 10(k) number: K070442 Device D… | 2003 |
| * | K070442 | Powerled Surgical Light SystemSummary page 1…g System 510(k) number: K031068 Predicate Device2: MAQUET POWERLED Surgical Light System 5 10(k) number: K070442 Device Description The Surgical Light ZF 720 is applicable for Open surgery, Endoscope surgery or other surgical procedur… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- 4 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K031068.
How does its category compare?
All FSY devicesFSY Light, Surgical, Ceiling Mounted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FSY
7in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · FSY
59in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FSY
11in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FSY
286in 2025
MAUDE reports naming product code FSY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 29 | 0 | 70 |
| 2008 | 2 | — | 0 | 53 |
| 2009 | 2 | — | 4 | 40 |
| 2010 | 5 | 130 | 3 | 72 |
| 2011 | 0 | — | 4 | 70 |
| 2012 | 2 | — | 4 | 171 |
| 2013 | 3 | 118 | 1 | 137 |
| 2014 | 7 | 59 | 0 | 139 |
| 2015 | 0 | — | 228 | 175 |
| 2016 | 0 | — | 0 | 182 |
| 2017 | 0 | — | 0 | 162 |
| 2018 | 0 | — | 2 | 316 |
| 2019 | 0 | — | 4 | 444 |
| 2020 | 0 | — | 0 | 439 |
| 2021 | 0 | — | 0 | 380 |
| 2022 | 0 | — | 0 | 430 |
| 2023 | 0 | — | 11 | 663 |
| 2024 | 0 | — | 0 | 541 |
| 2025 | 0 | — | 0 | 286 |
| 2026 | 0 | — | 4 | — |
What is it indicated for?
The Shadowless Operation Light ZF 720 is intended to be used to provide visible illumination of the surgical area or the
patient with high intensity and shadow free light during surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132551: ZF 720.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132551
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026