510(k) · Cleared
ClearedOricare L2700
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oricare, Inc. · FSY Light, Surgical, Ceiling Mounted
Cleared on Dec 18, 2012 as substantially equivalent to K070442 (Maquet S.A., 2007) and 1 other predicate after a 90-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Dec 18, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- FSY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K965130 (1997). 8 ancestors in all, the oldest K904965 (1991). No later device cites it as a predicate yet.
- Root · 4 generations backK965130 ChromophareBerchtold Holding GmbH · 1997
- 3 generations backK024132 Chromophare X 65Berchtold Holding GmbH · 2003
- 2 generations backK061317 ILEDTrumpf Kreuzer Medizin Systeme GmbH + Co.Kg · 2006 · Recalled
- 1 generation backK072072 Harmony Led-1 Surgical Lighting SystemSTERIS Corporation · 2007 · Recalled
- This deviceK122875 Oricare L2700Oricare, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K965130 | Chromophare | Berchtold Holding GmbH | 1997 | — |
| −3 | K024132 | Chromophare X 65 | Berchtold Holding GmbH | 2003 | — |
| −2 | K061317 | ILED | Trumpf Kreuzer Medizin Systeme GmbH + Co.Kg | 2006 | 7 |
| −1 | K072072 | Harmony Led-1 Surgical Lighting System | STERIS Corporation | 2007 | 1 |
| 0 (this device) | K122875 | Oricare L2700 | Oricare, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K070442 | Powerled Surgical Light SystemSummary page 1…ication Name: Surgical Lamp (21 CFR 878.4580, Product Code: FSY) Predicate Devices: Maquet PowerLED Surgical Lighting System (K070442) Steris Harmony LEO-i Surgical Lighting System (K(072072) Device Description / Technol… | 2007 |
| * | K072072 | Harmony Led-1 Surgical Lighting SystemSummary page 1…vices: Maquet PowerLED Surgical Lighting System (K070442) Steris Harmony LEO-i Surgical Lighting System (K(072072) Device Description / Technological Characteristics OL 2700 series Surgical Lamps are ceiling mounted Surgical Lamps, suitable… | 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 15 years and passes through 4 companies; a new generation was cleared every 5.2 years on median.
- 5 of the 8 ancestors have a recall of any class.
- 6 other devices also cite its predicate K070442.
How does its category compare?
All FSY devicesFSY Light, Surgical, Ceiling Mounted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Oricare L2700 Series Surgical Lamps provide illumination at varying illumination levels to the patient surgical area and provide video-visual procedural support for medical staff during surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122875 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122875: Oricare L2700.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122875
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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