510(k) · Cleared
ClearedALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
SurGenTec, LLC · KNW Instrument, Biopsy
Cleared on Apr 24, 2025 as substantially equivalent to K240664 (SurGenTec, LLC, 2024) and 2 other predicates after a 125-day review. Its family tree reaches back 13 generations to 1995. 1 of the 129 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 24, 2025
- Review
- 125 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K950697 (1995). 128 ancestors in all, the oldest K842956 (1984). No later device cites it as a predicate yet. 1 of the 129 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 9 generations between
- 3 generations backK171807 ES2 Neuromonitoring Accessory InstrumentsStryker Corporation · 2017
- 2 generations backK190163 ALARA Neuro Access KitSurGenTec, LLC · 2019
- 1 generation backK240664 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC · 2024
- This deviceK243945 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC · 2025
Show all 13 generations
- Root · 13 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 12 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 11 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 10 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 9 generations backK061854 Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine · 2006
- 8 generations backK063428 Xia Stainless Steel Spinal SystemStryker Spine · 2006
- 7 generations backK092631 Mantis Redux Spinal SystemStryker Spine · 2009
- 6 generations backK102235 Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010
- 5 generations backK122845 ES2 Spinal System Model 48280XXXXStryker Spine · 2012
- 4 generations backK140400 ES2 Neuromonitoring Accessory InstrumentsStryker Corporation · 2014
- 3 generations backK171807 ES2 Neuromonitoring Accessory InstrumentsStryker Corporation · 2017
- 2 generations backK190163 ALARA Neuro Access KitSurGenTec, LLC · 2019
- 1 generation backK240664 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC · 2024
- This deviceK243945 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC · 2025
Class I recalls in this family
- K980196 MD Tech Biopsy Set for Bone and Bone Marrow3 generations back · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −12 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −11 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −10 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −9 | K061854 | Xia Titanium Spinal System and Xia Stainless Steel Spinal System | Stryker Spine | 2006 | — |
| −8 | K063428 | Xia Stainless Steel Spinal System | Stryker Spine | 2006 | — |
| −7 | K092631 | Mantis Redux Spinal System | Stryker Spine | 2009 | — |
| −6 | K102235 | Mantis Spinal System & Mantis Redux Spinal System | Stryker Spine | 2010 | — |
| −5 | K122845 | ES2 Spinal System Model 48280XXXX | Stryker Spine | 2012 | — |
| −4 | K140400 | ES2 Neuromonitoring Accessory Instruments | Stryker Corporation | 2014 | — |
| −3 | K171807 | ES2 Neuromonitoring Accessory Instruments | Stryker Corporation | 2017 | — |
| −2 | K190163 | ALARA Neuro Access Kit | SurGenTec, LLC | 2019 | — |
| −1 | K240664 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | 2024 | — |
| 0 (this device) | K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 4 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 6 | 0 |
| 1996 | 5 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 1 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 6 | 0 |
| 2002 | 8 | 0 |
| 2003 | 8 | 0 |
| 2004 | 7 | 0 |
| 2005 | 10 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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 KNW device
- #1 K260572 Marrow Marxmanscore 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K240664 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)Summary page 5…Needle, BMA Needle Classification: 21 CFR 876.1075, 21 CFR 874.1820 Product Code: KNW, PDQ Predicate Device: ALARA Neuro Access Kit (K240664) ALARA Neuro Access Kit (K190163) Ranfac Bone Marrow Aspiration Needle (K13… | 2024 |
| * | K190163 | ALARA Neuro Access KitSummary page 5…075, 21 CFR 874.1820 Product Code: KNW, PDQ Predicate Device: ALARA Neuro Access Kit (K240664) ALARA Neuro Access Kit (K190163) Ranfac Bone Marrow Aspiration Needle (K131157) Reference Device: Avitus Bone Harvester (K17… | 2019 |
| * | K131157 | Ranfac Bone Marrow Aspiration NeedleSummary page 5…e: ALARA Neuro Access Kit (K240664) ALARA Neuro Access Kit (K190163) Ranfac Bone Marrow Aspiration Needle (K131157) Reference Device: Avitus Bone Harvester (K170539) Device Description: The ALARA BMA Neuro Access Kit utilizes a neuro… | 2013 |
| † | K170539 | Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K980196MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · 3 generations back · ◆ in the 1998 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 15 of the 128 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · KNW
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNW
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNW
1in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · KNW
1,667in 2025
MAUDE reports naming product code KNW, 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 | 6 | 94 | 1 | 766 |
| 2008 | 4 | 53 | 7 | 363 |
| 2009 | 6 | 35 | 3 | 351 |
| 2010 | 3 | 57 | 2 | 162 |
| 2011 | 10 | 64 | 5 | 67 |
| 2012 | 7 | 94 | 1 | 93 |
| 2013 | 3 | 100 | 1 (1) | 98 |
| 2014 | 8 | 95 | 3 | 193 |
| 2015 | 10 | 106 | 0 | 591 |
| 2016 | 9 | 127 | 5 | 297 |
| 2017 | 8 | 90 | 1 | 760 |
| 2018 | 7 | 71 | 0 | 1,012 |
| 2019 | 5 | 94 | 4 | 4,195 |
| 2020 | 8 | 92 | 0 | 5,120 |
| 2021 | 9 | 54 | 3 | 1,020 |
| 2022 | 8 | 203 | 3 | 535 |
| 2023 | 7 | 164 | 2 | 931 |
| 2024 | 5 | 114 | 1 | 1,283 |
| 2025 | 12 | 178 | 0 | 1,667 |
| 2026 | 7 | 29 | 4 (3) | — |
What is it indicated for?
The ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is indicated for aspiration of bone marrow or autologous blood.
The ALARA BMA Neuro Access Kit is indicated for pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback.
The ALARA BMAC Needle is intended for use in harvesting core biopsy samples of cancellous bone and/or bone marrow.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243945 · printed Nov 5, 2026
Cite this page
510(k) Report. “K243945: ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K243945
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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