510(k) · Cleared
Recalled · 2009Manan Gwi Guide Wire Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Device Technologies, Inc. · DRC Trocar
Cleared on Apr 6, 1998 as substantially equivalent to K851834 (Manan Manufacturing Co., Inc., 1985) after a 108-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it. It has been recalled once.
- Decided
- Apr 6, 1998
- Review
- 108 days
- Class
- Class II
- Product code
- DRC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K851834 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK851834 Manan Gwi Guide Wire IntroducerManan Manufacturing Co., Inc. · 1985
- This deviceK974745 Manan Gwi Guide Wire IntroducerMedical Device Technologies, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK021275 Micomed Posterior Doublerod SystemMicomed Ortho GmbH · 2002
Most influential descendants
Showing 1 of 1 · See all- K021275Micomed Posterior Doublerod SystemMicomed Ortho GmbH · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851834 | Manan Gwi Guide Wire Introducer | Manan Manufacturing Co., Inc. | 1985 | — |
| 0 (this device) | K974745 | Manan Gwi Guide Wire Introducer | Medical Device Technologies, Inc. | 1998 | — |
| +1 | K021275 | Micomed Posterior Doublerod System | Micomed Ortho GmbH | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 DRC? 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 DRC device
- #1 K241042 SafeSharp Transseptal Needle (CLICK071…score 9.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K851834 | Manan Gwi Guide Wire IntroducerSummary page 1…(352)338-0440 fax (352)338-0662 Manan™ Guide Wire Introducer Guide wire introducer Introducer, Percutaneous - 74DYR Product Name 510(k) No. Guide Wire Introducer : K851834 This introducer is made in various gauges from 16 to 21 ga, and in 3.8 or 7 cm lengths. The tip of the introducer is ground to a… | 1985 |
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 |
|---|---|---|---|
| K021275 | Micomed Posterior Doublerod System | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 1, 2009 | Not classified | Z-2018-2010 | Other | Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast Localization Needles, Soft Tissue Biopsy Needles, Vascular Access Needles, Bone Biopsy Needles, Access Needles, Galactography Kit… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All DRC devicesDRC Trocar: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRC
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DRC
Too few DRC 510(k)s in any year since 2007 to give a median.
Recalls per year · DRC
1in 2021
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DRC
69in 2025
MAUDE reports naming product code DRC, 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 | 1 | — | 0 | 106 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 1 | 17 |
| 2010 | 0 | — | 1 | 33 |
| 2011 | 1 | — | 0 | 68 |
| 2012 | 1 | — | 0 | 58 |
| 2013 | 1 | — | 1 | 37 |
| 2014 | 2 | — | 1 | 65 |
| 2015 | 0 | — | 0 | 52 |
| 2016 | 0 | — | 0 | 62 |
| 2017 | 2 | — | 0 | 70 |
| 2018 | 2 | — | 0 | 85 |
| 2019 | 0 | — | 1 (1) | 95 |
| 2020 | 0 | — | 0 | 108 |
| 2021 | 1 | — | 1 | 78 |
| 2022 | 2 | — | 0 | 61 |
| 2023 | 0 | — | 0 | 109 |
| 2024 | 2 | — | 0 | 105 |
| 2025 | 0 | — | 0 | 69 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Manan™ Guide Wire Introducer is intended for use as an anterior, single wall arterial percutaneous puncture.
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/K974745 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974745: Manan Gwi Guide Wire Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974745
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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