510(k) · Cleared
ClearedCelling Aspiration Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Smith Holdings, LLC · KNW Instrument, Biopsy
Cleared on May 24, 2018 as substantially equivalent to K980196 (Medical Device Technologies, Inc., 1998) and 1 other predicate after a 57-day review. Its family tree reaches back 7 generations to 1987. 1 of the 27 devices in its family, counting itself, has a Class I recall.
- Decided
- May 24, 2018
- Review
- 57 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K871390 (1987). 26 ancestors in all. No later device cites it as a predicate yet. 1 of the 27 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 deviceK180807 Celling Aspiration NeedleSpine Smith Holdings, LLC · 2018
Class I recalls in this family
- K980196 MD Tech Biopsy Set for Bone and Bone Marrowdirect predicate · 1998
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) | K180807 | Celling Aspiration Needle | Spine Smith Holdings, LLC | 2018 | — |
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 |
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 |
|---|---|---|---|
| * | K980196 | MD Tech Biopsy Set for Bone and Bone MarrowSummary page 4…NTIFICATION OF PREDICATE DEVICES: The Celling Aspiration Needle was determined to be substantially equivalent to the previously cleared Argon Bone Marrow Harvest Needle, K980196, Cleared February 3, 1998. The Celling Aspiration Needle is contract manufactured to the same specifications as the predicate in… | 1998 |
| * | K131157 | Ranfac Bone Marrow Aspiration NeedleSummary page 4…cate. The only difference is the color of the handle, needle length, and added depth markings. A secondary predicate is identified, Ranfac Bone Marrow Aspiration Needle, K131157, since the needle is currently being distributed by SpineSmith and testing was performed to ensure that it performed equivalent t… | 2013 |
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 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
- 5 of the 26 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K980196.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Celling Aspiration Needle is intended for use in aspirating bone marrow.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180807 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180807: Celling 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/K180807
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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