510(k) Report

510(k) · Cleared

Cleared

NT-1000

K052878510(k) TraditionalCleared Jan 23, 2006103-day reviewClass II21 CFR 882.4400

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

Neuro Therm, Inc. · GXD Generator, Lesion, Radiofrequency

Cleared on Jan 23, 2006 after a 103-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 18 later devices descend from it.

Decided
Jan 23, 2006
Review
103 days
Class
Class II
Product code
GXD
Recalls
None
Predicates
0

18 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2011: 1 descendant cleared2007: 2 descendants cleared2008: 1 descendant cleared2006: 1 descendant cleared2009: 1 descendant cleared2017: 1 descendant cleared2025: 2 descendants cleared2023: 2 descendants cleared2020: 1 descendant cleared2024: 2 descendants cleared2012: 1 descendant cleared2014: 1 descendant cleared2015: 1 descendant cleared20052010201520202025
  1. This deviceK052878 NT-1000Neuro Therm, Inc. · 2006
  2. Descendant · cites it directly · 7 of its ownK082051 Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc. · 2008
  3. Descendant · cites it directly · 5 of its ownK071482 Stryker RF Multi-Lesion Generator, Model 0406-900-000Synergetics, Inc. · 2007 · Recalled
  4. Descendant · cites it directly · 5 of its ownK061660 Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006
  5. Descendant · 2 generations on · 4 of its ownK083528 Smith & Nephew Bipolar Adapter Cable, Model 72200022Smith & Nephew, Inc. · 2009
  6. Descendant · 3 generations on · 3 of its ownK111262 Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar…Olsen Medical · 2012 · Recalled

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22008: 12009: 12011: 12012: 12013: 12014: 12015: 12017: 12020: 12023: 22024: 22025: 2
2006high 2 (2007) · low 0 (2010)2026

Most influential descendants

Showing 5 of 18 · See all
  • K082051Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc. · 2008 · cites it directly7descendants
  • K071482Stryker RF Multi-Lesion Generator, Model 0406-900-000Synergetics, Inc. · 2007 · cites it directly5descendants
  • K061660Stryker RF Parallel Bipolar Adaptor CableStryker Instruments · 2006 · cites it directly5descendants
  • K083528Smith & Nephew Bipolar Adapter Cable, Model 72200022Smith & Nephew, Inc. · 2009 · 2 generations on4descendants
  • K111262Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/ Adapters…Olsen Medical · 2012 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K052878NT-1000Neuro Therm, Inc.2006—
+1K082051Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc.2008—
+1K071482Stryker RF Multi-Lesion Generator, Model 0406-900-000Synergetics, Inc.20071
+1K061660Stryker RF Parallel Bipolar Adaptor CableStryker Instruments2006—
+2K083528Smith & Nephew Bipolar Adapter Cable, Model 72200022Smith & Nephew, Inc.2009—
+3K111262Electrosurgical Monopolar Cable/Adapters, Electrosurgical Bipolar Cable/…Olsen Medical20122

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
200810
200910
201110
201210
201310
201410
201510
201710
202010
202320
202420
202520
FIG. 1 — Lineage of K052878, 2006–2025Source: 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), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GXD? 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 GXD device

  1. #1 K251247 GX1 Radiofrequency Generator Kit…score 11.0 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K082051Cosman G4 Radiofrequency Generator, Model RFG-4Cosman Medical, Inc.20087
K071482Stryker RF Multi-Lesion Generator, Model 0406-900-000Synergetics, Inc.20075
K061660Stryker RF Parallel Bipolar Adaptor CableStryker Instruments20065
K111576NT 2000 Lesioning GeneratorNeuro Therm, Inc.20113
K132136Single Use Grounding PadLccs Products Limited20130
K063480Stryker RF Intradiscal Adaptor, Model 406-750Stryker Corp.20070

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, K082051 (Cosman Medical, Inc., 2008) has gone furthest, with 7 descendants of its own.

How does its category compare?

All GXD devices

GXD Generator, Lesion, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GXD

1in 2025

2007: 42008: 22010: 12011: 22017: 22019: 12020: 22022: 12023: 22024: 22025: 1
2007high 4 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXD

185in 2007

2007: 185 days median
2007high 185 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GXD

1in 2023

2010: 12016: 12019: 12023: 1
2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · GXD

88in 2025

2007: 102008: 102009: 122010: 692011: 892012: 772013: 1192014: 642015: 672016: 512017: 832018: 1562019: 1952020: 1382021: 1542022: 842023: 542024: 632025: 88
2007high 195 (2019) · low 10 (2007)2025

MAUDE reports naming product code GXD, 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
20074185010
20082—010
20090—012
20101—169
20112—089
20120—077
20130—0119
20140—064
20150—067
20160—151
20172—083
20180—0156
20191—1195
20202—0138
20210—0154
20221—084
20232—154
20242—063
20251—088
20260—0—

What is it indicated for?

The NT 1000 is intended for use to create lesions in neural tissue. The NT 1000 is to be used with separately approved lesion/temperature probes such as NeuroTherm radiofrequency probes, Smith & Nephew SpinecathTM and AcuthermTM catheters, and Radionics DiskTrodeTM radiofrequency probes.

Indications for use as stated in the FDA 510(k) statement.

More from Neuro Therm, Inc.

3 FDA decisions under this applicant name. See the company

  • K122503Parallax Balloon Inflatable Bone Tamp-10 MM Balloon Parallax Balloon Inflatable Bone Tamp-15 MM Balloon…Neuro Therm, Inc. · 2013
  • K111576NT 2000 Lesioning GeneratorNeuro Therm, Inc. · 20114 recalls

Recent decisions in GXD

The GXD category page

  • K251247GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1…Boston Scientific Neuromodulation Corporation · 2025
  • K242057COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)Avanos Medical, Inc. · 2024
  • K232632Racz Neurostat RF GeneratorEpimed International · 2024
  • K231675OneRF Ablation SystemNeuroone Medical Technologies Corp. · 2023
  • K220122APEX 6Rf Innovations, Inc. · 2023

https://510kreport.com/device/K052878 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052878: NT-1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052878

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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