510(k) · Cleared
ClearedPeriView FLEX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Surgical Technologies America · KTI Bronchoscope Accessory
Cleared on Sep 21, 2017 as substantially equivalent to K162611 (Spiration, Inc., 2017) after a 147-day review. Its family tree reaches back 2 generations to 1991. 3 later devices descend from it.
- Decided
- Sep 21, 2017
- Review
- 147 days
- Class
- Class II
- Product code
- KTI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914181 (1991). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK914181 Wang/Mill-Rose Transbronchial Aspiration NeedleMill-Rose Laboratory · 1991 · Recalled
- 1 generation backK162611 PeriFLEXSpiration, Inc. · 2017
- This deviceK171232 PeriView FLEXOlympus Surgical Technologies America · 2017
- Descendant · cites it directly · 1 of its ownK221206 Compass Steerable NeedleSerpex Medical, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK252874 Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01Serpex Medical, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK181193 PeriView FLEXOlympus Surgical Technologies America · 2018
Most influential descendants
Showing 3 of 3 · See all- K221206Compass Steerable NeedleSerpex Medical, Inc. · 2022 · cites it directly1descendant
- K252874Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01Serpex Medical, Inc. · 2025 · 2 generations on0descendants
- K181193PeriView FLEXOlympus Surgical Technologies America · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914181 | Wang/Mill-Rose Transbronchial Aspiration Needle | Mill-Rose Laboratory | 1991 | 4 |
| −1 | K162611 | PeriFLEX | Spiration, Inc. | 2017 | — |
| 0 (this device) | K171232 | PeriView FLEX | Olympus Surgical Technologies America | 2017 | — |
| +1 | K221206 | Compass Steerable Needle | Serpex Medical, Inc. | 2022 | — |
| +2 | K252874 | Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 | Serpex Medical, Inc. | 2025 | — |
| +1 | K181193 | PeriView FLEX | Olympus Surgical Technologies America | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 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 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? (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 |
|---|---|---|---|
| * | K162611 | PeriFLEXSummary page 4…Name: PeriView FLEX Generic/Common Name: Aspiration Needle Predicate Devices Spiration, Inc. PeriFLEX K162611 6 Gyrus ACMI Peri… | 2017 |
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?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 25.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K221206 (Serpex Medical, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K162611.
How does its category compare?
All KTI devicesKTI Bronchoscope Accessory: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
This device is intended to be used through a compatible bronchoscope for the collection of tissue from the intrapulmonary regions. Do not use for any purpose other than its intended use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171232: PeriView FLEX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171232
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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