510(k) · Cleared
ClearedPS Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Photonic Optische Gerate Gesmbh & Cokg · FFS Image, Illumination, Fiberoptic, For Endoscope
Cleared on Mar 5, 2007 as substantially equivalent to K983714 (Cogent Light Technologies, Inc., 1998) and 3 other predicates after a 266-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Mar 5, 2007
- Review
- 266 days
- Class
- Class II
- Product code
- FFS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K983714 (1998). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK983714 Solartec Source 270, Model # 90123Cogent Light Technologies, Inc. · 1998
- This deviceK061622 PS SeriesPhotonic Optische Gerate Gesmbh & Cokg · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983714 | Solartec Source 270, Model # 90123 | Cogent Light Technologies, Inc. | 1998 | — |
| 0 (this device) | K061622 | PS Series | Photonic Optische Gerate Gesmbh & Cokg | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 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 FFS? 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 |
|---|---|---|---|
| * | K983714 | Solartec Source 270, Model # 90123Summary page 1…Predicate Device 510(k) r class, code, 21CFR Cogent/WelchAllyn Solartec Source ST270 K(983714 11, FFS, 876,1500 (CL300) Cogent/WelchiAllyn Micro Link en… | 1998 |
| * | K001698 | Micro Link Endoscopic Fiber Cable, Model B1-90159Summary page 1…K(983714 11, FFS, 876,1500 (CL300) Cogent/WelchiAllyn Micro Link endoscopic K(001698 II, FFS&KOD 876.1500 fiber cable ________II,… | 2000 |
| * | K022384 | Xenon Fiberoptic Light Source, Model 1300 XSBPSummary page 1…fiber cable ________II, HBI&FST, 878.4580 Isolux America 1300 XSBP K(022384 II, HET, 884.1720 Isolux America 1125 XSB 1(599… | 2002 |
| * | K991572 | Isolux Surgical HeadlightSummary page 1…____ ____ ___ __ _ ___ ____ ___ I, EA Z, 872.4630 _I~Solux Amer-ica Fiber optic surgical K991572 II, FST, 878.4580 Device Description The cold light sources of the PS series consist of short arc metal… | 1999 |
| * | — | 1125 XSB 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.
What does this lineage say?
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K983714.
How does its category compare?
All FFS devicesFFS Image, Illumination, Fiberoptic, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FFS
3in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · FFS
74in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FFS
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FFS
5in 2024
MAUDE reports naming product code FFS, 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 | 74 | 1 | 12 |
| 2008 | 0 | — | 0 | 17 |
| 2009 | 0 | — | 0 | 14 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 17 |
| 2020 | 0 | — | 0 | 56 |
| 2021 | 0 | — | 0 | 57 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The device is used to provide light for endoscopic devices. Those devices can be connected directly to the light source or by fiber bundles or single fibers. The device is intended for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061622 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061622: PS Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061622
Report an extraction error
Are you the manufacturer?
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