510(k) · Cleared
ClearedPunctureneedle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ferguson Medical · KNW Instrument, Biopsy
Cleared on Mar 19, 1998 as substantially equivalent to K760775 (Terumo America, Inc., 1976) and 3 other predicates after a 545-day review. Its family tree reaches back 2 generations to 1982.
- Decided
- Mar 19, 1998
- Review
- 545 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K813338 (1982). 5 ancestors in all, the oldest K760775 (1976). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K813338 | Biopsy Needles & Trays | American Pharmaseal Div. Ahsc | 1982 | 2 |
| −1 | K961185 | Daum Biopsyneedle | Ferguson Medical | 1996 | — |
| 0 (this device) | K963794 | Punctureneedle | Ferguson Medical | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1985 | 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.
Planning a device in KNW? 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? (4)
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 |
|---|---|---|---|
| * | K760775 | Terumo Disposable Spinal NeedleSummary page 1…l name: Aspiration needle, puncture needle, probe needle, irrigation needle, injection needle, etc. Proprietary name: PunctureNeedle B. Substantial equivalence: Terumo (K760775), Wilson~-Cook (K851953, K851957), Daum (K961185), and others. C. Device description: The PunctureNeedle 1is a standard needle… | 1976 |
| * | K851953 | Hawkin NeedleSummary page 1…e, puncture needle, probe needle, irrigation needle, injection needle, etc. Proprietary name: PunctureNeedle B. Substantial equivalence: Terumo (K760775), Wilson~-Cook (K851953, K851957), Daum (K961185), and others. C. Device description: The PunctureNeedle 1is a standard needle to puncture precise anat… | 1985 |
| * | K851957 | Chiba NeedleSummary page 1…re needle, probe needle, irrigation needle, injection needle, etc. Proprietary name: PunctureNeedle B. Substantial equivalence: Terumo (K760775), Wilson~-Cook (K851953, K851957), Daum (K961185), and others. C. Device description: The PunctureNeedle 1is a standard needle to puncture precise anatomical lo… | 1985 |
| * | K961185 | Daum BiopsyneedleSummary page 1…needle, irrigation needle, injection needle, etc. Proprietary name: PunctureNeedle B. Substantial equivalence: Terumo (K760775), Wilson~-Cook (K851953, K851957), Daum (K961185), and others. C. Device description: The PunctureNeedle 1is a standard needle to puncture precise anatomical locations and injec… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 14.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 PunctureNeedle device is intended for use in puncturing precise anatomical locations (including but not limited to cysts, lesions, fluid spaces, etc.) and aspirating or injecting various fluids or contents. The device may be utilized under MRI guidance.
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/K963794 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963794: Punctureneedle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963794
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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