510(k) · Cleared
ClearedManan Automatic Cutting Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Manan Medical Products, Inc. · KNW Instrument, Biopsy
Cleared on Jan 8, 1998 after a 44-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Jan 8, 1998
- Review
- 44 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK974446 Manan Automatic Cutting NeedleManan Medical Products, Inc. · 1998
- Descendant · cites it directly · 2 of its ownK981166 Accucore Core Biopsy Needle Catalog Codes:581014, 581614, 581618…Inrad · 1998
- Descendant · cites it directly · 1 of its ownK162588 Möller Medical Biopsy Needles and SystemsMoller Medical GmbH · 2017
- Descendant · 2 generations on · 0 of its ownK242128 Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy…Xaga Surgical · 2025
- Descendant · 2 generations on · 0 of its ownK052435 Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK013109 SonopsyHakko Medical Co., Ltd. · 2002
Most influential descendants
Showing 5 of 5 · See all- K981166Accucore Core Biopsy Needle Catalog Codes:581014, 581614, 581618, 582018, 582518…Inrad · 1998 · cites it directly2descendants
- K162588Möller Medical Biopsy Needles and SystemsMoller Medical GmbH · 2017 · cites it directly1descendant
- K242128Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall…Xaga Surgical · 2025 · 2 generations on0descendants
- K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc. · 2005 · 2 generations on0descendants
- K013109SonopsyHakko Medical Co., Ltd. · 2002 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974446 | Manan Automatic Cutting Needle | Manan Medical Products, Inc. | 1998 | — |
| +1 | K981166 | Accucore Core Biopsy Needle Catalog Codes:581014, 581614, 581618, 582018… | Inrad | 1998 | — |
| +1 | K162588 | Möller Medical Biopsy Needles and Systems | Moller Medical GmbH | 2017 | — |
| +2 | K242128 | Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and… | Xaga Surgical | 2025 | — |
| +2 | K052435 | Pneumrx Family of Biopsy Needles and Kits | Pneumrx, Inc. | 2005 | — |
| +2 | K013109 | Sonopsy | Hakko Medical Co., Ltd. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2017 | 1 | 0 |
| 2025 | 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? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K981166 (Inrad, 1998) has gone furthest, with 2 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?
Needle can be used for obtaining core and/or aspiration biopsies of various tissues (Prostate, lung, kidney, liver, spleen, thyroid, adrenals, abdominal soft tissue masses, breast). For Breast Biopsy this product is for diagnosis only-not for therapeutic use.
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/K974446 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974446: Manan Automatic Cutting Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974446
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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