510(k) Report

510(k) · Cleared

Cleared

Nucleotome L Kit

K942987510(k) TraditionalCleared Oct 30, 1995497-day reviewClass I21 CFR 878.4820

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Surgical Dynamics, Inc. · GET Motor, Surgical Instrument, Pneumatic Powered

Cleared on Oct 30, 1995 after a 497-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 50 later devices descend from it.

Decided
Oct 30, 1995
Review
497 days
Class
Class I
Product code
GET
Recalls
None
Predicates
0

50 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2009: 3 descendants cleared2004: 2 descendants cleared1998: 1 descendant cleared2003: 1 descendant cleared2006: 2 descendants cleared2018: 3 descendants cleared2014: 1 descendant cleared1999: 2 descendants cleared2010: 1 descendant cleared2011: 1 descendant cleared2002: 1 descendant cleared2007: 2 descendants cleared2008: 1 descendant cleared2013: 3 descendants cleared2016: 3 descendants cleared2012: 5 descendants cleared2021: 1 descendant cleared2024: 2 descendants cleared2017: 2 descendants cleared2019: 1 descendant cleared2025: 4 descendants cleared2026: 6 descendants cleared2023: 2 descendants cleared1995200020052010201520202025
  1. This deviceK942987 Nucleotome L KitSurgical Dynamics, Inc. · 1995
  2. Descendant · cites it directly · 28 of its ownK032473 Dekompressor Percutaneous Discectomy ProbeStryker Instruments · 2003 · Recalled
  3. Descendant · cites it directly · 20 of its ownK974464 Oratec Spinecath Intradiscal CatheterOratec Interventions, Inc. · 1998
  4. Descendant · cites it directly · 17 of its ownK040919 Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · Recalled
  5. Descendant · 2 generations on · 16 of its ownK993854 Ora-50 S Autotemp Electrothermal Spine System and AccessoriesOratec Interventions, Inc. · 1999
  6. Descendant · 2 generations on · 14 of its ownK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

1998: 11999: 22002: 12003: 12004: 22006: 22007: 22008: 12009: 32010: 12011: 12012: 52013: 32014: 12016: 32017: 22018: 32019: 12021: 12023: 22024: 22025: 42026: 6
1998high 6 (2026) · low 0 (2000)2026

Most influential descendants

Showing 5 of 50 · See all
  • K032473Dekompressor Percutaneous Discectomy ProbeStryker Instruments · 2003 · cites it directly28descendants
  • K974464Oratec Spinecath Intradiscal CatheterOratec Interventions, Inc. · 1998 · cites it directly20descendants
  • K040919Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · cites it directly17descendants
  • K993854Ora-50 S Autotemp Electrothermal Spine System and AccessoriesOratec Interventions, Inc. · 1999 · 2 generations on16descendants
  • K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006 · 2 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K942987Nucleotome L KitSurgical Dynamics, Inc.1995—
+1K032473Dekompressor Percutaneous Discectomy ProbeStryker Instruments20033
+1K974464Oratec Spinecath Intradiscal CatheterOratec Interventions, Inc.1998—
+1K040919Nucleotome Probe Set, Model 21200Clarus Medical, LLC20041
+2K993854Ora-50 S Autotemp Electrothermal Spine System and AccessoriesOratec Interventions, Inc.1999—
+2K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199920
200210
200310
200420
200620
200720
200810
200930
201010
201110
201250
201330
201410
201630
201720
201830
201910
202110
202320
202420
202540
202660
FIG. 1 — Lineage of K942987, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 GET? 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
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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? (50)

See all 50

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K032473Dekompressor Percutaneous Discectomy ProbeStryker Instruments200328
K974464Oratec Spinecath Intradiscal CatheterOratec Interventions, Inc.199820
K040919Nucleotome Probe Set, Model 21200Clarus Medical, LLC200417
K092877Indiscal Aspiration Device and AccessoriesBaylis Medical Co., Inc.20090

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 GET devices

GET Motor, Surgical Instrument, Pneumatic Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GET

FDA has decided no GET device since 2007.

Median 510(k) review, days · GET

Too few GET 510(k)s in any year since 2007 to give a median.

Recalls per year · GET

1in 2013

2008: 472013: 1
2007high 47 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GET

8in 2025

2007: 332008: 82009: 112010: 352011: 2802012: 482013: 342014: 262015: 432016: 292017: 452018: 462019: 152020: 152021: 92022: 132023: 62024: 192025: 8
2007high 280 (2011) · low 6 (2023)2025

MAUDE reports naming product code GET, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—033
20080—478
20090—011
20100—035
20110—0280
20120—048
20130—134
20140—026
20150—043
20160—029
20170—045
20180—046
20190—015
20200—015
20210—09
20220—013
20230—06
20240—019
20250—08
20260—0—

More from Surgical Dynamics, Inc.

12 FDA decisions under this applicant name. See the company

  • K960046Surgical Dynamics 30K Working Channel ScopeSurgical Dynamics, Inc. · 1996
  • K954193Surgical Dynamics 30K Working Channel Scope & Instrument SetSurgical Dynamics, Inc. · 1995
  • K950495Sugical Dynamics Endoscopy Irrigation Pump, Catalog #3-4000Surgical Dynamics, Inc. · 1995
  • K931109Nucleotome E KitSurgical Dynamics, Inc. · 1994
  • K921950Surgical Dynamics Discography SystemSurgical Dynamics, Inc. · 1993

Recent decisions in GET

The GET category page

  • K960473Aesculap Power System HandpieceAesculap, Inc. · 1996
  • K955174Sodem High Speed System for Neurosurgery & Median StyernotomySodem Diffusion SA · 1996
  • K954076Midas Rex Drill Attachments & Twist DrillsMidas Rex Pneumatic Tools, Inc. · 1995
  • K953433Midas Rex Telescoping SystemMidas Rex Pneumatic Tools, Inc. · 19952 recalls
  • K953432Rotating, Fixed Footed, Fixed Shield Attachments, Dissecting ToolsMidas Rex Pneumatic Tools, Inc. · 19951 recall

https://510kreport.com/device/K942987 · printed Nov 5, 2026

Cite this page

510(k) Report. “K942987: Nucleotome L Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K942987

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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