510(k) · Cleared
ClearedPeriFLEX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spiration, Inc. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Feb 9, 2017 as substantially equivalent to K914181 (Mill-Rose Laboratory, 1991) after a 143-day review. Its family tree reaches back 1 generation to 1991. 12 later devices descend from it.
- Decided
- Feb 9, 2017
- Review
- 143 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914181 (1991). 12 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK914181 Wang/Mill-Rose Transbronchial Aspiration NeedleMill-Rose Laboratory · 1991 · Recalled
- This deviceK162611 PeriFLEXSpiration, Inc. · 2017
- Descendant · cites it directly · 7 of its ownK173760 Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 5 of its ownK193534 Monarch PlatformAuris Health, Inc. · 2020 · Recalled
- Descendant · cites it directly · 3 of its ownK171232 PeriView FLEXOlympus Surgical Technologies America · 2017
- Descendant · 3 generations on · 2 of its ownK211493 Monarch PlatformAuris Health, Inc. · 2021 · Recalled
- Descendant · 4 generations on · 1 of its ownK243219 MONARCH™ Platform (MON-000008)Auris Health, Inc. · 2025 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K173760Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc. · 2018 · cites it directly7descendants
- K193534Monarch PlatformAuris Health, Inc. · 2020 · 2 generations on5descendants
- K171232PeriView FLEXOlympus Surgical Technologies America · 2017 · cites it directly3descendants
- K211493Monarch PlatformAuris Health, Inc. · 2021 · 3 generations on2descendants
- K243219MONARCH™ Platform (MON-000008)Auris Health, Inc. · 2025 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914181 | Wang/Mill-Rose Transbronchial Aspiration Needle | Mill-Rose Laboratory | 1991 | 4 |
| 0 (this device) | K162611 | PeriFLEX | Spiration, Inc. | 2017 | — |
| +1 | K173760 | Monarch Endoscopy Platform (Monarch Platform) | Auris Surgical Robotics, Inc. | 2018 | 1 |
| +2 | K193534 | Monarch Platform | Auris Health, Inc. | 2020 | 4 |
| +1 | K171232 | PeriView FLEX | Olympus Surgical Technologies America | 2017 | — |
| +3 | K211493 | Monarch Platform | Auris Health, Inc. | 2021 | 2 |
| +4 | K243219 | MONARCH™ Platform (MON-000008) | Auris Health, Inc. | 2025 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 EOQ? 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 EOQ device
- #1 K223299 Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu®…score 18.4 · 11 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.
What descends from it? (12)
See all 122 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?
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · EOQ
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOQ
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOQ
25in 2025
Class I (28 since 2007) Class II/III not classified
Adverse event reports per year · EOQ
6,546in 2025
MAUDE reports naming product code EOQ, 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 | 2 | — | 0 | 39 |
| 2008 | 2 | — | 0 | 87 |
| 2009 | 3 | 24 | 0 | 114 |
| 2010 | 0 | — | 0 | 100 |
| 2011 | 0 | — | 1 | 96 |
| 2012 | 2 | — | 4 | 93 |
| 2013 | 4 | 178 | 0 | 93 |
| 2014 | 3 | 302 | 0 | 98 |
| 2015 | 6 | 206 | 0 | 132 |
| 2016 | 3 | 262 | 1 | 297 |
| 2017 | 4 | 136 | 0 | 337 |
| 2018 | 7 | 212 | 0 | 279 |
| 2019 | 11 | 147 | 1 | 654 |
| 2020 | 10 | 103 | 1 | 515 |
| 2021 | 15 | 169 | 9 | 1,358 |
| 2022 | 11 | 134 | 5 | 2,541 |
| 2023 | 12 | 160 | 18 (4) | 5,064 |
| 2024 | 13 | 130 | 4 | 6,051 |
| 2025 | 20 | 147 | 25 (24) | 6,546 |
| 2026 | 9 | 206 | 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/K162611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162611: PeriFLEX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162611
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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