510(k) · Cleared
ClearedRanfac Aspiration Needle with Adjustable Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ranfac, Corp. · KNW Instrument, Biopsy
Cleared on Sep 11, 2014 as substantially equivalent to K131157 (Ranfac, Corp., 2013) and 1 other predicate after a 147-day review. Its family tree reaches back 7 generations to 1987. 1 of the 36 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it.
- Decided
- Sep 11, 2014
- Review
- 147 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K871390 (1987). 30 ancestors in all. 5 later devices descend from it, 1 citing it directly. 1 of the 36 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK871390 Bard Biopty Biopsy SystemC.R. Bard, Inc. · 1987
- 6 generations backK962969 Medical Device Technologies, Inc.UltraMedical Device Technologies, Inc. · 1996
- 5 generations backK982085 Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic…Medical Device Technologies, Inc. · 1998
- 4 generations backK982960 Meical Device Technologies, Inc. Tru-Core Disposable Automatic…Medical Device Technologies, Inc. · 1998 · Recalled
- 3 generations backK990839 Tru-Core I Reusable Biopsy InstrumentMedical Device Technologies, Inc. · 1999
- 2 generations backK051506 Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt…Sterylab S.R.L. · 2005
- 1 generation backK131157 Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013
- This deviceK140991 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 · 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
- Descendant · 2 generations on · 0 of its ownK260572 Marrow MarxmanMedimetrix, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK203397 Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray…Biopsybell S.R.L. · 2021
Class I recalls in this family
- K980196 MD Tech Biopsy Set for Bone and Bone Marrow3 generations back · 1998
Most influential descendants
Showing 5 of 5 · See all- K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp. · 2015 · cites it directly4descendants
- 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
- K260572Marrow MarxmanMedimetrix, LLC · 2026 · 2 generations on0descendants
- K203397Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or…Biopsybell S.R.L. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K871390 | Bard Biopty Biopsy System | C.R. Bard, Inc. | 1987 | — |
| −6 | K962969 | Medical Device Technologies, Inc.Ultra | Medical Device Technologies, Inc. | 1996 | — |
| −5 | K982085 | Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy… | Medical Device Technologies, Inc. | 1998 | — |
| −4 | K982960 | Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy Instrument | Medical Device Technologies, Inc. | 1998 | 2 |
| −3 | K990839 | Tru-Core I Reusable Biopsy Instrument | Medical Device Technologies, Inc. | 1999 | — |
| −2 | K051506 | Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut… | Sterylab S.R.L. | 2005 | — |
| −1 | K131157 | Ranfac Bone Marrow Aspiration Needle | Ranfac, Corp. | 2013 | — |
| 0 (this device) | K140991 | Ranfac Aspiration Needle with Adjustable Guide | Ranfac, Corp. | 2014 | — |
| +1 | K150563 | Marrow Cellution Bone Marrow Aspiration Needle | Ranfac, Corp. | 2015 | — |
| +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 | — |
| +2 | K260572 | Marrow Marxman | Medimetrix, LLC | 2026 | — |
| +2 | K203397 | Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)-… | Biopsybell S.R.L. | 2021 | — |
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 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (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 5…991, page 2 of 4 [ Ranfac \ ¥ Precision instruments for specialized applications 510(k) Summary Predicate Device: 510(k) Predicate Description Manufactured By Number K131157 Ranfac Bone Marrow Aspiration Needle Ranfac Corp. K121181 SwannShidi Bone Marrow Aspiration Needle Alliance Partners, LLC Backgro… | 2013 |
| * | K121181 | Swannshidi Bone Marrow Aspiration NeedleSummary page 5…specialized applications 510(k) Summary Predicate Device: 510(k) Predicate Description Manufactured By Number K131157 Ranfac Bone Marrow Aspiration Needle Ranfac Corp. K121181 SwannShidi Bone Marrow Aspiration Needle Alliance Partners, LLC Background The Ranfac Aspiration Needle with Adjustable Guide is… | 2012 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150563 | Marrow Cellution Bone Marrow Aspiration Needle | 2015 | 4 |
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 27 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 5 of the 30 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K150563 (Ranfac, Corp., 2015) has gone furthest, with 4 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. 2014, 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 Aspiration Needle with Adjustable Guide is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.
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/K140991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140991: Ranfac Aspiration Needle with Adjustable Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140991
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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