510(k) · Cleared
ClearedPencil-Grip Fna Syringe Holder and Effortless Needle Remover
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tao & Tao Technologyt, Inc. · KNW Instrument, Biopsy
Cleared on Dec 9, 1997 after a 159-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Dec 9, 1997
- Review
- 159 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK972496 Pencil-Grip Fna Syringe Holder and Effortless Needle RemoverTao & Tao Technologyt, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK200278 CytoCorePraxis Medical, LLC · 2020
Most influential descendants
Showing 1 of 1 · See all- K200278CytoCorePraxis Medical, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972496 | Pencil-Grip Fna Syringe Holder and Effortless Needle Remover | Tao & Tao Technologyt, Inc. | 1997 | — |
| +1 | K200278 | CytoCore | Praxis Medical, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K200278 | CytoCore | 2020 | 0 |
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?
- Of its descendants, K200278 (Praxis Medical, LLC, 2020) has gone furthest, with 0 descendants of its own.
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 TAO ASPIRATOR™ is a device to hold a 10cc syringe for performing fine needle aspiration of a palpable mass with one hand, while stabilizing the mass to be aspirated with the other hand. It is equipped with a release button for automatically drawing back the syringe plunger, and is designed to be held in a pencil-grip manner. This device places the hand relatively close to the needle tip while the hand is in a position of natural function, enabling…
Read the full statement (145 words)
The TAO ASPIRATOR™ is a device to hold a 10cc syringe for performing fine needle aspiration of a palpable mass with one hand, while stabilizing the mass to be aspirated with the other hand. It is equipped with a release button for automatically drawing back the syringe plunger, and is designed to be held in a pencil-grip manner. This device places the hand relatively close to the needle tip while the hand is in a position of natural function, enabling the needle movement using fine motor control of the hand.
The PLASTIC FINGER™ is an accessory to the TAO ASPIRATOR to facilitate specimen procurement. It facilitates needle removal so that air can be drawn into the syringe, and the aspirated material in the needle and needle hub can then be expressed onto slides. It can also be used to grip slides for fixation and staining.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972496 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972496: Pencil-Grip Fna Syringe Holder and Effortless Needle Remover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972496
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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