510(k) · Cleared
ClearedGetinge/Castle Optiview Series Surgical Light
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Getinge/Castle, Inc. · FSY Light, Surgical, Ceiling Mounted
Cleared on Mar 3, 1998 after a 125-day review. The FDA summary names its predicate without a number.
- Decided
- Mar 3, 1998
- Review
- 125 days
- Class
- Class II
- Product code
- FSY
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (5)
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 |
|---|---|---|---|
| * | — | ALM Prismatic®, model 7001 and 9001 series Named without a submission number | |
| * | — | Amsco SQ240 Named without a submission number | |
| * | — | Berchtold Chromophare®, model C-570, C-570/570 and C-570/570/570 Named without a submission number | |
| * | — | ALM Illuminator Spotlight Named without a submission number | |
| * | — | Berchtold Chromophare C-300 Named without a submission number |
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.
How does its category compare?
All FSY devicesFSY Light, Surgical, Ceiling Mounted: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Getinge/Castle OptiView®Surgical Lights are to be used in the same, (general type and configuration), surgical operatory theatres, and out-patient surgery centers that currently employ various models of the referenced predicate devices.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974084 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974084: Getinge/Castle Optiview Series Surgical Light.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974084
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026