510(k) · Cleared
ClearedLiPPS Analyzer, LiPPS Wire Pressure Guide Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Bywave Sensing Medical Technology Co., Ltd. · DQX Wire, Guide, Catheter
Cleared on Feb 18, 2021 as substantially equivalent to K142598 (Opsens, Inc., 2015) and 1 other predicate after a 240-day review. Its family tree reaches back 7 generations to 1982.
- Decided
- Feb 18, 2021
- Review
- 240 days
- Class
- Class II
- Product code
- DQX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K823434 (1982). 18 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK823434 Mikro-Tip Catheter Pressure TransducerMillar Instruments, Inc. · 1982
- 6 generations backK965140 Cardiometrics Wavewire/Wavemap Pressure SystemCardio Metrics, Inc. · 1997
- 5 generations backK021219 Smartwire/Smartmap Pressure SystemJomed, Inc. · 2002
- 4 generations backK070487 Smartwire Pressure Guide Wire, Model 66XXVolcano Corporation · 2007
- 3 generations backK100930 Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300…Volcano Corporation · 2010
- 2 generations backK111395 Primewire Prestige PlusVolcano Corporation · 2011 · Recalled
- 1 generation backK142598 Opto Wire and OptoMonitor SystemOpsens, Inc. · 2015
- This deviceK201720 LiPPS Analyzer, LiPPS Wire Pressure Guide WireBeijing Bywave Sensing Medical Technology Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K823434 | Mikro-Tip Catheter Pressure Transducer | Millar Instruments, Inc. | 1982 | — |
| −6 | K965140 | Cardiometrics Wavewire/Wavemap Pressure System | Cardio Metrics, Inc. | 1997 | — |
| −5 | K021219 | Smartwire/Smartmap Pressure System | Jomed, Inc. | 2002 | — |
| −4 | K070487 | Smartwire Pressure Guide Wire, Model 66XX | Volcano Corporation | 2007 | — |
| −3 | K100930 | Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300, 8300J | Volcano Corporation | 2010 | — |
| −2 | K111395 | Primewire Prestige Plus | Volcano Corporation | 2011 | 1 |
| −1 | K142598 | Opto Wire and OptoMonitor System | Opsens, Inc. | 2015 | — |
| 0 (this device) | K201720 | LiPPS Analyzer, LiPPS Wire Pressure Guide Wire | Beijing Bywave Sensing Medical Technology Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 2004 | 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 DQX? 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 DQX device
- #1 K213854 SavvyWirescore 15.7 · 10 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 |
|---|---|---|---|
| * | K142598 | Opto Wire and OptoMonitor SystemSummary page 4…Regulation Number: 21 CFR 870.2870/ 21 CFR 870.1330 Review Panel: Cardiovascular Classification: II 5.4. Predicate Device 510(k) Number: K142598 Device Name: OptoWire and OptoMonitor System Manufacturer: Opsens, Inc. 510(k) Number: K111395 Device… | 2015 |
| * | K111395 | Primewire Prestige PlusSummary page 4…: II 5.4. Predicate Device 510(k) Number: K142598 Device Name: OptoWire and OptoMonitor System Manufacturer: Opsens, Inc. 510(k) Number: K111395 Device Name: PrimeWire PRESTIGE® Plus Pressure Guide Wire Manufacturer: Volcano Corporation 5.5. Indications f… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 39 years and passes through 6 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 18 ancestors has a recall of any class.
- 3 other devices also cite its predicate K142598.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · DQX
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
MAUDE reports naming product code DQX, 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 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
What is it indicated for?
LiPPSTM Intravascular Pressure Sensing System is intended to be used in an environment like cathlab and for use in blood vessels, including coronary and peripheral vessels, to measure intravascular pressure during angiography and/or interventional procedures. Pressure measurements are obtained to provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel diseases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201720 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201720: LiPPS Analyzer, LiPPS Wire Pressure Guide Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201720
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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