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 Aug 9, 2024 as substantially equivalent to K131157 (Ranfac, Corp., 2013) and 1 other predicate after a 154-day review. Its family tree reaches back 12 generations to 1995. 1 of the 129 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Aug 9, 2024
- Review
- 154 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K950697 (1995). 127 ancestors in all, the oldest K842956 (1984). 1 later device descends from it, 1 citing it directly. 1 of the 129 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 8 generations between
- 3 generations backK140400 ES2 Neuromonitoring Accessory InstrumentsStryker Corporation · 2014
- 2 generations backK171807 ES2 Neuromonitoring Accessory InstrumentsStryker Corporation · 2017
- 1 generation backK190163 ALARA Neuro Access KitSurGenTec, LLC · 2019
- This deviceK240664 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC · 2024
- Descendant · cites it directly · 0 of its ownK243945 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC · 2025
Show all 12 generations
- Root · 12 generations backK950697 Depuy Motech Moss Miami Spinal System - Pedicle FixationDepuy Motech · 1995
- 11 generations backK050461 Xia 4.5 Spinal SystemStryker Spine · 2005
- 10 generations backK052761 Modification to: Xia 4.5 Spinal SystemStryker Spine · 2005
- 9 generations backK060361 Xia Spinal System, Xia 4.5 Spinal SystemStryker Spine · 2006 · Recalled
- 8 generations backK061854 Xia Titanium Spinal System and Xia Stainless Steel Spinal SystemStryker Spine · 2006
- 7 generations backK063428 Xia Stainless Steel Spinal SystemStryker Spine · 2006
- 6 generations backK092631 Mantis Redux Spinal SystemStryker Spine · 2009
- 5 generations backK102235 Mantis Spinal System & Mantis Redux Spinal SystemStryker Spine · 2010
- 4 generations backK122845 ES2 Spinal System Model 48280XXXXStryker Spine · 2012
- 3 generations backK140400 ES2 Neuromonitoring Accessory InstrumentsStryker Corporation · 2014
- 2 generations backK171807 ES2 Neuromonitoring Accessory InstrumentsStryker Corporation · 2017
- 1 generation backK190163 ALARA Neuro Access KitSurGenTec, LLC · 2019
- This deviceK240664 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC · 2024
Class I recalls in this family
- K980196 MD Tech Biopsy Set for Bone and Bone Marrow3 generations back · 1998
Most influential descendants
Showing 1 of 1 · See all- K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K950697 | Depuy Motech Moss Miami Spinal System - Pedicle Fixation | Depuy Motech | 1995 | — |
| −11 | K050461 | Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −10 | K052761 | Modification to: Xia 4.5 Spinal System | Stryker Spine | 2005 | — |
| −9 | K060361 | Xia Spinal System, Xia 4.5 Spinal System | Stryker Spine | 2006 | 1 |
| −8 | K061854 | Xia Titanium Spinal System and Xia Stainless Steel Spinal System | Stryker Spine | 2006 | — |
| −7 | K063428 | Xia Stainless Steel Spinal System | Stryker Spine | 2006 | — |
| −6 | K092631 | Mantis Redux Spinal System | Stryker Spine | 2009 | — |
| −5 | K102235 | Mantis Spinal System & Mantis Redux Spinal System | Stryker Spine | 2010 | — |
| −4 | K122845 | ES2 Spinal System Model 48280XXXX | Stryker Spine | 2012 | — |
| −3 | K140400 | ES2 Neuromonitoring Accessory Instruments | Stryker Corporation | 2014 | — |
| −2 | K171807 | ES2 Neuromonitoring Accessory Instruments | Stryker Corporation | 2017 | — |
| −1 | K190163 | ALARA Neuro Access Kit | SurGenTec, LLC | 2019 | — |
| 0 (this device) | K240664 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K131157 | Ranfac Bone Marrow Aspiration NeedleSummary page 4…tion: 21 CFR 876.1075, 21 CFR 874.1820 Product Code: KNW, PDQ Primary Predicate: Ranfac Bone Marrow Aspiration Needle, Ranfac Corp. (K131157) Additional Predicate: ALARA Neuro Access Kit, SurGenTec LLC (K190163) Device Description: The ALARA BMA Neuro Access Kit… | 2013 |
| * | K190163 | ALARA Neuro Access KitSummary page 4…KNW, PDQ Primary Predicate: Ranfac Bone Marrow Aspiration Needle, Ranfac Corp. (K131157) Additional Predicate: ALARA Neuro Access Kit, SurGenTec LLC (K190163) Device Description: The ALARA BMA Neuro Access Kit utilizes a neuromonitoring platform in providing the surgeon with nerve / ro… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | 2025 | 0 |
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 29 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 15 of the 127 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K243945 (SurGenTec, LLC, 2025) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K131157.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240664: 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 6, 2026. https://510kreport.com/device/K240664
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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