510(k) · Cleared
ClearedGaltTWS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Galt Medical Corp. · DRB Stylet, Catheter
Cleared on May 30, 2019 as substantially equivalent to K992664 (Tfx Medical Group, 2000) and 2 other predicates after a 247-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- May 30, 2019
- Review
- 247 days
- Class
- Class II
- Product code
- DRB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K000313 (2000). 8 ancestors in all, the oldest K920884 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK000313 Tearaway Introducer SheathXentek Medical, Inc. · 2000 · Recalled
- 3 generations backK043525 Catheter IntroducerGalt Medical Corp. · 2005 · Recalled
- 2 generations backK112398 Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway…Galt Medical · 2012 · Recalled
- 1 generation backK152528 Attachable Cath Lab Hemostasis ValveGalt Medical Corp. · 2015
- This deviceK182660 GaltTWSGalt Medical Corp. · 2019
- Descendant · cites it directly · 0 of its ownK220280 Arrow Stiffening StyletArrow International, LLC (A subsidiary of Teleflex, Inc.) · 2022
Most influential descendants
Showing 1 of 1 · See all- K220280Arrow Stiffening StyletArrow International, LLC (A subsidiary of Teleflex, Inc.) · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000313 | Tearaway Introducer Sheath | Xentek Medical, Inc. | 2000 | 1 |
| −3 | K043525 | Catheter Introducer | Galt Medical Corp. | 2005 | 3 |
| −2 | K112398 | Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer… | Galt Medical | 2012 | 2 |
| −1 | K152528 | Attachable Cath Lab Hemostasis Valve | Galt Medical Corp. | 2015 | — |
| 0 (this device) | K182660 | GaltTWS | Galt Medical Corp. | 2019 | — |
| +1 | K220280 | Arrow Stiffening Stylet | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 DRB? 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 DRB device
- #1 K220280 Arrow Stiffening Styletscore 5.1 · 5 generations · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K992664 | TFX Medical Stylet CatheterSummary page 4…ter Stylet (DRB), 21 CFR 870.1380 Device Classification: Class II (Cardiovascular) Predicate Device: TFX Medical Coated Stylet (K992664) Guidewire (K982559) Gateway Hemostasis Valve (152528) Manufacturer:… | 2000 |
| * | K982559 | GuidewireSummary page 4…1 CFR 870.1380 Device Classification: Class II (Cardiovascular) Predicate Device: TFX Medical Coated Stylet (K992664) Guidewire (K982559) Gateway Hemostasis Valve (152528) Manufacturer: Galt Medical… | 1999 |
| * | K152528 | Attachable Cath Lab Hemostasis ValveSummary page 5…K182660 hub, or connected to a flushable adjustable hub using the Galt Gateway Hemostasis Valve {K152528). Comparison of Technological Characteristics: The subject device GaltTWS Stylet and the predicate device TFX… | 2015 |
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 |
|---|---|---|---|
| K220280 | Arrow Stiffening Stylet | 2022 | 0 |
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 19 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K220280 (Arrow International, LLC (A subsidiary of Teleflex, Inc.), 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DRB devicesDRB Stylet, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · DRB
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DRB
Too few DRB 510(k)s in any year since 2007 to give a median.
Recalls per year · DRB
No recall names DRB since 2007.
Adverse event reports per year · DRB
152in 2025
MAUDE reports naming product code DRB, 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 | 0 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 54 |
| 2011 | 0 | — | 0 | 28 |
| 2012 | 0 | — | 0 | 40 |
| 2013 | 0 | — | 0 | 53 |
| 2014 | 1 | — | 0 | 67 |
| 2015 | 0 | — | 0 | 66 |
| 2016 | 0 | — | 0 | 56 |
| 2017 | 1 | — | 0 | 63 |
| 2018 | 0 | — | 0 | 40 |
| 2019 | 2 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 92 |
| 2021 | 0 | — | 0 | 97 |
| 2022 | 1 | — | 0 | 94 |
| 2023 | 0 | — | 0 | 82 |
| 2024 | 0 | — | 0 | 116 |
| 2025 | 0 | — | 0 | 152 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GaltTWS Stylet is a percutaneous catheter stylet placed inside a catheter, lead, or cannula to stiffen the device for placement or extraction.
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/K182660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182660: GaltTWS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182660
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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