510(k) · Cleared
ClearedRanfac Bone Marrow Aspiration Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ranfac, Corp. · KNW Instrument, Biopsy
Cleared on Oct 22, 2013 as substantially equivalent to K050795 (Orthovita, Inc., 2005) and 2 other predicates after a 181-day review. Its family tree reaches back 6 generations to 1987. 1 of the 38 devices in its family, counting itself, has a Class I recall. 12 later devices descend from it.
- Decided
- Oct 22, 2013
- Review
- 181 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K871390 (1987). 25 ancestors in all. 12 later devices descend from it, 9 citing it directly. 1 of the 38 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK871390 Bard Biopty Biopsy SystemC.R. Bard, Inc. · 1987
- 5 generations backK962969 Medical Device Technologies, Inc.UltraMedical Device Technologies, Inc. · 1996
- 4 generations backK982085 Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic…Medical Device Technologies, Inc. · 1998
- 3 generations backK982960 Meical Device Technologies, Inc. Tru-Core Disposable Automatic…Medical Device Technologies, Inc. · 1998 · Recalled
- 2 generations backK990839 Tru-Core I Reusable Biopsy InstrumentMedical Device Technologies, Inc. · 1999
- 1 generation backK051506 Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt…Sterylab S.R.L. · 2005
- This deviceK131157 Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013
- Descendant · cites it directly · 5 of its ownK140991 Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp. · 2014
- Descendant · cites it directly · 4 of its ownK150563 Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp. · 2015
- Descendant · cites it directly · 1 of its ownK240664 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC · 2024
- Descendant · 2 generations on · 1 of its ownK223612 Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation · 2023
- Descendant · 2 generations on · 1 of its ownK202287 Ran-Flex-B Bone Marrow Aspiration NeedleRanfac Corporation · 2020
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K980196 MD Tech Biopsy Set for Bone and Bone Marrow2 generations back · 1998
Most influential descendants
Showing 5 of 12 · See all- K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp. · 2014 · cites it directly5descendants
- K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp. · 2015 · cites it directly4descendants
- K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC · 2024 · cites it directly1descendant
- K223612Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation · 2023 · 2 generations on1descendant
- K202287Ran-Flex-B Bone Marrow Aspiration NeedleRanfac Corporation · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K871390 | Bard Biopty Biopsy System | C.R. Bard, Inc. | 1987 | — |
| −5 | K962969 | Medical Device Technologies, Inc.Ultra | Medical Device Technologies, Inc. | 1996 | — |
| −4 | K982085 | Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy… | Medical Device Technologies, Inc. | 1998 | — |
| −3 | K982960 | Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy Instrument | Medical Device Technologies, Inc. | 1998 | 2 |
| −2 | K990839 | Tru-Core I Reusable Biopsy Instrument | Medical Device Technologies, Inc. | 1999 | — |
| −1 | K051506 | Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut… | Sterylab S.R.L. | 2005 | — |
| 0 (this device) | K131157 | Ranfac Bone Marrow Aspiration Needle | Ranfac, Corp. | 2013 | — |
| +1 | K140991 | Ranfac Aspiration Needle with Adjustable Guide | Ranfac, Corp. | 2014 | — |
| +1 | K150563 | Marrow Cellution Bone Marrow Aspiration Needle | Ranfac, Corp. | 2015 | — |
| +1 | K240664 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | SurGenTec, LLC | 2024 | — |
| +2 | K223612 | Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) | Ranfac Corporation | 2023 | — |
| +2 | K202287 | Ran-Flex-B Bone Marrow Aspiration Needle | Ranfac Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 1 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K050795 | Imbibe Bone Marrow Aspiration NeedleSummary page 2…510(k) Summary Predicate Device: 510(k) Number Predicate Description Manufactured By K050795 Imbibe Bone Marrow Aspiration Needle IOrthovita, Inc. K 100665 MarrowMax Bone Marrow Aspiration Needl… | 2005 |
| * | K100665 | Marromax B One Marrow Aspiration Needle Kit, Models 50083-XX, 50084-XXSummary page 2…Predicate Description Manufactured By K050795 Imbibe Bone Marrow Aspiration Needle IOrthovita, Inc. K 100665 MarrowMax Bone Marrow Aspiration Needle Kit NeedleTech K05 1506 Sterylab Best Bone Harvesting System… | 2010 |
| * | K051506 | Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft…Summary page 2…K050795 Imbibe Bone Marrow Aspiration Needle IOrthovita, Inc. K 100665 MarrowMax Bone Marrow Aspiration Needle Kit NeedleTech K05 1506 Sterylab Best Bone Harvesting System Sterylab Device Description: The Ranfac Bone Mar… | 2005 |
What descends from it? (12)
See all 129 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140991 | Ranfac Aspiration Needle with Adjustable Guide | 2014 | 5 |
| K150563 | Marrow Cellution Bone Marrow Aspiration Needle | 2015 | 4 |
| K240664 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | 2024 | 1 |
| K260572 | Marrow Marxman | 2026 | 0 |
| K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) | 2025 | 0 |
| K213213 | Arthrex Vortex Threaded Bone Marrow Recovery Needle | 2021 | 0 |
| K190177 | J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, | 2019 | 0 |
| K183146 | Ranfac Cartilage Biopsy Needle | 2019 | 0 |
| K180807 | Celling Aspiration Needle | 2018 | 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 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- 5 of the 25 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K140991 (Ranfac, Corp., 2014) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K050795.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Ranfac Bone Marrow Aspiration Needle Is Intended for use In aspirating bone marrow.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131157 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131157: Ranfac Bone Marrow Aspiration Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131157
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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