510(k) · Cleared
ClearedManan General Purpose Introducer Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Device Technologies, Inc. · KNW Instrument, Biopsy
Cleared on Jan 9, 1998 as substantially equivalent to K940024 (Manan Medical Products, Inc., 1994) and 1 other predicate after a 7-day review. Its family tree reaches back 1 generation to 1988. 3 later devices descend from it.
- Decided
- Jan 9, 1998
- Review
- 7 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K881957 (1988). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK881957 Hawkins-Akins Blunt Needle Access KitN-S Medical Products · 1988 · Recalled
- This deviceK980004 Manan General Purpose Introducer NeedleMedical Device Technologies, Inc. · 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 · cites it directly · 0 of its ownK052435 Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc. · 2005
Most influential descendants
Showing 3 of 3 · See all- 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 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881957 | Hawkins-Akins Blunt Needle Access Kit | N-S Medical Products | 1988 | 1 |
| 0 (this device) | K980004 | Manan General Purpose Introducer Needle | Medical Device Technologies, Inc. | 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 | — |
| +1 | K052435 | Pneumrx Family of Biopsy Needles and Kits | Pneumrx, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2017 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K940024 | Manan General Purpose Introducer NeedleSummary page 1…dle, biopsy needle §878.4800-Manual Surgical Instrument for General Use; Disposable Aspiration and Injection Needle Product Name 510(k) No. Co-Axial Introducer Needles K940024 Hawkins-Akins Blunt Needle K881957 The Manan Co-Axial Introducer Needle is a general purpose introducer-type needle assembly int… | 1994 |
| * | K881957 | Hawkins-Akins Blunt Needle Access KitSummary page 1…l Surgical Instrument for General Use; Disposable Aspiration and Injection Needle Product Name 510(k) No. Co-Axial Introducer Needles K940024 Hawkins-Akins Blunt Needle K881957 The Manan Co-Axial Introducer Needle is a general purpose introducer-type needle assembly intended for a range of biopsy applica… | 1988 |
What descends from it? (3)
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?
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 Manan™ Co-Axial Introducer Needle is intended for a range of biopsy applications of soft tissue.
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/K980004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980004: Manan General Purpose Introducer Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980004
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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