510(k) · Cleared
ClearedCivco Seed Implant Needle Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CIVCO Medical Instruments Co., Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Apr 14, 1988 after a 114-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Apr 14, 1988
- Review
- 114 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK875241 Civco Seed Implant Needle GuideCIVCO Medical Instruments Co., Inc. · 1988
- Descendant · cites it directly · 6 of its ownK972672 Brachystepper Stepping Unit, Brachystepper Needle Guide Template…Barzell-Whitmore Maroon Bells, Inc. · 1997
- Descendant · 2 generations on · 1 of its ownK131161 EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper…CIVCO Medical Instruments Co., Inc. · 2013
- Descendant · cites it directly · 1 of its ownK982696 InterplantBurdette Medical Systems, Inc. · 1999 · Recalled
- Descendant · 3 generations on · 0 of its ownK171040 Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and…Koelis · 2017
- Descendant · 2 generations on · 0 of its ownK131428 RadvisionAcoustic Medsystems, Inc. · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K972672Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand Support…Barzell-Whitmore Maroon Bells, Inc. · 1997 · cites it directly6descendants
- K131161EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper; Micro-Touch…CIVCO Medical Instruments Co., Inc. · 2013 · 2 generations on1descendant
- K982696InterplantBurdette Medical Systems, Inc. · 1999 · cites it directly1descendant
- K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and…Koelis · 2017 · 3 generations on0descendants
- K131428RadvisionAcoustic Medsystems, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K875241 | Civco Seed Implant Needle Guide | CIVCO Medical Instruments Co., Inc. | 1988 | — |
| +1 | K972672 | Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand… | Barzell-Whitmore Maroon Bells, Inc. | 1997 | — |
| +2 | K131161 | EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper; Micro-Touch… | CIVCO Medical Instruments Co., Inc. | 2013 | — |
| +1 | K982696 | Interplant | Burdette Medical Systems, Inc. | 1999 | 1 |
| +3 | K171040 | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD… | Koelis | 2017 | — |
| +2 | K131428 | Radvision | Acoustic Medsystems, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 2 | 0 |
| 2013 | 2 | 0 |
| 2017 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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? (8)
3 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, K972672 (Barzell-Whitmore Maroon Bells, Inc., 1997) has gone furthest, with 6 descendants of its own.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
https://510kreport.com/device/K875241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K875241: Civco Seed Implant Needle Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K875241
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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