510(k) · Cleared
ClearedCompass Steerable Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Serpex Medical, Inc. · KTI Bronchoscope Accessory
Cleared on Aug 25, 2022 as substantially equivalent to K171232 (Olympus Surgical Technologies America, 2017) and 1 other predicate after a 121-day review. Its family tree reaches back 6 generations to 1991. 1 later device descends from it.
- Decided
- Aug 25, 2022
- Review
- 121 days
- Class
- Class II
- Product code
- KTI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K914181 (1991). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK914181 Wang/Mill-Rose Transbronchial Aspiration NeedleMill-Rose Laboratory · 1991 · Recalled
- 5 generations backK963252 TBANBoston Scientific Corp · 1996
- 4 generations backK040018 Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412Boston Scientific Corp · 2004
- 3 generations backK142839 GenCut Core Biopsy SystemCovidien, LLC · 2015
- 2 generations backK163537 Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 gaCovidien, LLC · 2017
- 1 generation backK182188 Ion Endoluminal System ; Flexision Biopsy NeedleIntuitive Surgical · 2019 · Recalled
- This deviceK221206 Compass Steerable NeedleSerpex Medical, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK252874 Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01Serpex Medical, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01Serpex Medical, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914181 | Wang/Mill-Rose Transbronchial Aspiration Needle | Mill-Rose Laboratory | 1991 | 4 |
| −5 | K963252 | TBAN | Boston Scientific Corp | 1996 | — |
| −4 | K040018 | Excelon Transbronchial Aspiration Needle, Models 6410, 6411, 6412 | Boston Scientific Corp | 2004 | — |
| −3 | K142839 | GenCut Core Biopsy System | Covidien, LLC | 2015 | — |
| −2 | K163537 | Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga | Covidien, LLC | 2017 | — |
| −1 | K182188 | Ion Endoluminal System ; Flexision Biopsy Needle | Intuitive Surgical | 2019 | 5 |
| 0 (this device) | K221206 | Compass Steerable Needle | Serpex Medical, Inc. | 2022 | — |
| +1 | K252874 | Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 | Serpex Medical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 KTI? 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 KTI device
- #1 K261274 EchoTip Ultra® Endobronchial HD Ultrasound…score 15.0 · 12 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 |
|---|---|---|---|
| * | K171232 | PeriView FLEXSummary page 4…DICATE DEVICE: Proprietary Name: PeriView Flex Common/Usual Name: Aspiration Needle Classification Name: Bronchoscope Accessory 510K Number: K171232 SECONDARY PREDICATE DEVICE: Proprietary Name: Ion™ Endoluminal System; Flexision™ Biopsy Needle Common/Usual Name:… | 2017 |
| * | K182188 | Ion Endoluminal System ; Flexision Biopsy NeedleSummary page 4…stem; Flexision™ Biopsy Needle Common/Usual Name: Aspiration Needle Classification Name: Bronchoscope (Flexible or Rigid) and Accessories 510K Number: K182188 Serpex Medical, Inc. Compass Steerable Needle 1 of 6 REFERENCE DEVICE: Proprie… | 2019 |
| † | K151396 | MIVI Mi-AXUS Guide Catheter | 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 |
|---|---|---|---|
| K252874 | Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 | 2025 | 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 31 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K252874 (Serpex Medical, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K171232.
How does its category compare?
All KTI devicesKTI Bronchoscope Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · KTI
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTI
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTI
198in 2025
MAUDE reports naming product code KTI, 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 | 3 |
| 2008 | 1 | — | 0 | 11 |
| 2009 | 1 | — | 0 | 9 |
| 2010 | 0 | — | 0 | 8 |
| 2011 | 1 | — | 0 | 17 |
| 2012 | 0 | — | 1 | 12 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 2 | — | 0 | 2 |
| 2016 | 3 | 140 | 0 | 7 |
| 2017 | 3 | 115 | 0 | 9 |
| 2018 | 1 | — | 1 | 14 |
| 2019 | 1 | — | 0 | 27 |
| 2020 | 1 | — | 0 | 37 |
| 2021 | 1 | — | 0 | 47 |
| 2022 | 3 | 137 | 0 | 131 |
| 2023 | 4 | 168 | 0 | 130 |
| 2024 | 0 | — | 0 | 149 |
| 2025 | 5 | 61 | 0 | 198 |
| 2026 | 3 | 98 | 0 | — |
What is it indicated for?
The Compass Steerable Needle is a steerable biopsy needle intended be used through a compatible working channel bronchoscope or Medtronic Extended Working Channel (EWC) for the collection of tissue from the intrapulmonary regions.
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/K221206 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221206: Compass Steerable Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221206
Report an extraction error
Are you the manufacturer?
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