510(k) · Cleared
ClearedNucleotome
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Instrument Development Laboratories, Inc. · HSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
Cleared on Nov 29, 1984 after a 37-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 29 later devices descend from it.
- Decided
- Nov 29, 1984
- Review
- 37 days
- Class
- Class I
- Product code
- HSZ
- Recalls
- None
- Predicates
- 0
29 later devices descend from it, 2 citing it directly.
- This deviceK844131 NucleotomeMedical Instrument Development Laboratories, Inc. · 1984
- Descendant · cites it directly · 28 of its ownK032473 Dekompressor Percutaneous Discectomy ProbeStryker Instruments · 2003 · Recalled
- Descendant · cites it directly · 17 of its ownK040919 Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · Recalled
- Descendant · 2 generations on · 14 of its ownK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006
- Descendant · 3 generations on · 13 of its ownK093062 Vertos Medical Mild Device KitX-Sten Corp. · 2010
- Descendant · 4 generations on · 7 of its ownK180876 DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K032473Dekompressor Percutaneous Discectomy ProbeStryker Instruments · 2003 · cites it directly28descendants
- K040919Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · cites it directly17descendants
- K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006 · 2 generations on14descendants
- K093062Vertos Medical Mild Device KitX-Sten Corp. · 2010 · 3 generations on13descendants
- K180876DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K844131 | Nucleotome | Medical Instrument Development Laboratories, Inc. | 1984 | — |
| +1 | K032473 | Dekompressor Percutaneous Discectomy Probe | Stryker Instruments | 2003 | 3 |
| +1 | K040919 | Nucleotome Probe Set, Model 21200 | Clarus Medical, LLC | 2004 | 1 |
| +2 | K062038 | X-Sten Mild Tool Kit, Model MTK-0001 | X-Sten Corp. | 2006 | — |
| +3 | K093062 | Vertos Medical Mild Device Kit | X-Sten Corp. | 2010 | — |
| +4 | K180876 | DTRAX Spinal System | Providence Medical Technology, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 HSZ? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (29)
See all 292 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, K032473 (Stryker Instruments, 2003) has gone furthest, with 28 descendants of its own.
How does its category compare?
All HSZ devicesHSZ Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSZ
FDA has decided no HSZ device since 2007.
Median 510(k) review, days · HSZ
Too few HSZ 510(k)s in any year since 2007 to give a median.
Recalls per year · HSZ
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSZ
4in 2025
MAUDE reports naming product code HSZ, 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 | 0 | — | 0 | 111 |
| 2008 | 0 | — | 0 | 13 |
| 2009 | 0 | — | 0 | 14 |
| 2010 | 0 | — | 0 | 11 |
| 2011 | 0 | — | 1 | 3 |
| 2012 | 0 | — | 0 | 27 |
| 2013 | 0 | — | 1 | 411 |
| 2014 | 0 | — | 0 | 18 |
| 2015 | 0 | — | 0 | 20 |
| 2016 | 0 | — | 0 | 27 |
| 2017 | 0 | — | 0 | 24 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 27 |
| 2022 | 0 | — | 0 | 35 |
| 2023 | 0 | — | 0 | 39 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K844131 · printed Nov 5, 2026
Cite this page
510(k) Report. “K844131: Nucleotome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K844131
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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