510(k) · Cleared
ClearedManan Brest Tumor Localization Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Manan Manufacturing Co., Inc. · GAA Needle, Aspiration And Injection, Disposable
Cleared on Oct 14, 1986 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Oct 14, 1986
- Review
- 14 days
- Class
- Class I
- Product code
- GAA
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK863848 Manan Brest Tumor Localization NeedleManan Manufacturing Co., Inc. · 1986
- Descendant · cites it directly · 0 of its ownK962615 Tumorlocalizer MriFerguson Medical · 1998
- Descendant · cites it directly · 0 of its ownK974741 Manan Accura NeedleMedical Device Technologies, Inc. · 1998 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K863848 | Manan Brest Tumor Localization Needle | Manan Manufacturing Co., Inc. | 1986 | — |
| +1 | K962615 | Tumorlocalizer Mri | Ferguson Medical | 1998 | — |
| +1 | K974741 | Manan Accura Needle | Medical Device Technologies, Inc. | 1998 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GAA? 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 GAA device
- #1 K223625 CapnoSpot™ Pneumothorax Decompression Indicatorscore 5.1 · 1 generation · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
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, K962615 (Ferguson Medical, 1998) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GAA devicesGAA Needle, Aspiration And Injection, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAA
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · GAA
Too few GAA 510(k)s in any year since 2007 to give a median.
Recalls per year · GAA
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAA
348in 2025
MAUDE reports naming product code GAA, 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 | 0 | — | 0 | 12 |
| 2008 | 0 | — | 1 | 32 |
| 2009 | 0 | — | 2 | 20 |
| 2010 | 0 | — | 2 | 18 |
| 2011 | 1 | — | 0 | 9 |
| 2012 | 0 | — | 0 | 24 |
| 2013 | 0 | — | 0 | 33 |
| 2014 | 0 | — | 0 | 24 |
| 2015 | 0 | — | 0 | 32 |
| 2016 | 0 | — | 0 | 45 |
| 2017 | 0 | — | 0 | 85 |
| 2018 | 0 | — | 0 | 122 |
| 2019 | 0 | — | 10 | 153 |
| 2020 | 0 | — | 0 | 102 |
| 2021 | 0 | — | 5 | 108 |
| 2022 | 0 | — | 2 | 74 |
| 2023 | 1 | — | 0 | 118 |
| 2024 | 0 | — | 0 | 181 |
| 2025 | 0 | — | 0 | 348 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K863848 · printed Nov 6, 2026
Cite this page
510(k) Report. “K863848: Manan Brest Tumor Localization Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K863848
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026