510(k) · Cleared
ClearedMorrison Steerable Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apriomed AB · KNW Instrument, Biopsy
Cleared on Jun 9, 2015 as substantially equivalent to K980122 (Medical Device Technologies, Inc., 1998) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Jun 9, 2015
- Review
- 90 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K851831 (1985). 10 ancestors in all. 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 | K851831 | Manan Franseene Needle | Manan Manufacturing Co., Inc. | 1985 | — |
| −1 | K980122 | Manan Soft Tissue Biopsy Needles | Medical Device Technologies, Inc. | 1998 | — |
| 0 (this device) | K150625 | Morrison Steerable Needle | Apriomed AB | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 5 | 0 |
| 1987 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 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.
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? (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 |
|---|---|---|---|
| * | K980122 | Manan Soft Tissue Biopsy NeedlesSummary page 4…Biopsy Needle) Common/Usual Names: Angiotech Chiba Biopsy Needle Classification Names: Instrument Biopsy 510(k) number: K980122 Product Code: KNW Proprietary Name: Pan Chiba Cytological Aspirating Biopsy Needle Common/Usual Names:… | 1998 |
| * | K970872 | Pan (Chiba Aspirating Needle)Summary page 4…ing Biopsy Needle Common/Usual Names: Pan Chiba Cytological Aspirating Biopsy Needle Classification Names: Instrument Biopsy 510(k) number: K970872 Product Code: KNW 5.4 Device Description The sterile, single use, Morrison Steerable Needle consists of the hous… | 1997 |
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 30 years and passes through 3 companies; a new generation was cleared every 17.4 years on median.
- None of the 10 ancestors has a recall.
- 4 other devices also cite its predicate K980122.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Morrison Steerable Needle is intended for percutaneous injection and aspiration procedures, and tissue sampling in kidney, liver, muscle and subcutaneous tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150625: Morrison Steerable Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150625
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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