510(k) · Cleared
ClearedPrecision Optics Image Coupler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precise Optics · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Oct 19, 1990 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Oct 19, 1990
- Review
- 79 days
- Class
- Class II
- Product code
- FET
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK903458 Precision Optics Image CouplerPrecise Optics · 1990
- Descendant · cites it directly · 7 of its ownK021502 Oscar, Model OE3000Orthosonics, Ltd. · 2002
- Descendant · 2 generations on · 3 of its ownK051053 Oscar, Model OE3000DBOrthosonics, Ltd. · 2005
- Descendant · 2 generations on · 2 of its ownK063531 Series 3 Lotus Laparoscopic Ultrasound Surgery SystemSra Developments, Ltd. · 2007
- Descendant · 3 generations on · 1 of its ownK151101 Lotus Series 4 Ultrasonic Surgical System & AccessoriesSra Developments, Ltd. · 2015
- Descendant · 3 generations on · 1 of its ownK083830 Oscar Bone ResectorOrthosonics, Ltd. · 2009
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K021502Oscar, Model OE3000Orthosonics, Ltd. · 2002 · cites it directly7descendants
- K051053Oscar, Model OE3000DBOrthosonics, Ltd. · 2005 · 2 generations on3descendants
- K063531Series 3 Lotus Laparoscopic Ultrasound Surgery SystemSra Developments, Ltd. · 2007 · 2 generations on2descendants
- K151101Lotus Series 4 Ultrasonic Surgical System & AccessoriesSra Developments, Ltd. · 2015 · 3 generations on1descendant
- K083830Oscar Bone ResectorOrthosonics, Ltd. · 2009 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K903458 | Precision Optics Image Coupler | Precise Optics | 1990 | — |
| +1 | K021502 | Oscar, Model OE3000 | Orthosonics, Ltd. | 2002 | — |
| +2 | K051053 | Oscar, Model OE3000DB | Orthosonics, Ltd. | 2005 | — |
| +2 | K063531 | Series 3 Lotus Laparoscopic Ultrasound Surgery System | Sra Developments, Ltd. | 2007 | — |
| +3 | K151101 | Lotus Series 4 Ultrasonic Surgical System & Accessories | Sra Developments, Ltd. | 2015 | — |
| +3 | K083830 | Oscar Bone Resector | Orthosonics, Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
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.
Planning a device in FET? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FET device
- #1 K242067 Visera Elite Iii Video System Center Olympus…score 18.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K021502 (Orthosonics, Ltd., 2002) has gone furthest, with 7 descendants of its own.
How does its category compare?
All FET devicesFET Endoscopic Video Imaging System/Component, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FET
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FET
166in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FET
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FET
14,530in 2025
MAUDE reports naming product code FET, 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 | 1 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 25 |
| 2017 | 3 | 119 | 0 | 66 |
| 2018 | 3 | 98 | 0 | 67 |
| 2019 | 3 | 25 | 0 | 72 |
| 2020 | 5 | 106 | 0 | 3,043 |
| 2021 | 1 | — | 0 | 5,300 |
| 2022 | 2 | — | 0 | 6,156 |
| 2023 | 1 | — | 2 | 8,199 |
| 2024 | 2 | — | 1 | 13,153 |
| 2025 | 6 | 166 | 0 | 14,530 |
| 2026 | 3 | 69 | 0 | — |
https://510kreport.com/device/K903458 · printed Nov 5, 2026
Cite this page
510(k) Report. “K903458: Precision Optics Image Coupler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K903458
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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