510(k) · Cleared
ClearedThe Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient Monitors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medizin Systeme Boeblingen GmbH · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Feb 17, 2006 as substantially equivalent to K014159 (Philips Medical Systems, Inc., 2002) and 14 other predicates after an 18-day review. Its family tree reaches back 20 generations to 1994. 222 later devices descend from it.
- Decided
- Feb 17, 2006
- Review
- 18 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 16
Its longest line of descent runs back 20 generations to K941811 (1994). 133 ancestors in all, the oldest K872781 (1987). 222 later devices descend from it, 20 citing it directly.
- Root · 20 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 16 generations between
- 3 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- 2 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
- 1 generation backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
- This deviceK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
- Descendant · cites it directly · 221 of its ownK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled
- Descendant · cites it directly · 211 of its ownK061052 The Philips Intellivue Patient Monitors, Models…Philips Medical Systems North America, Inc. · 2006
- Descendant · cites it directly · 188 of its ownK062283 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90…Philips Medical Systems North America, Inc. · 2006
- Descendant · cites it directly · 176 of its ownK062392 Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006
- Descendant · 2 generations on · 175 of its ownK063725 MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
Show all 20 generations
- Root · 20 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 19 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 18 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 17 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 16 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 15 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 14 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 13 generations backK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- 12 generations backK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
- 11 generations backK030038 Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal…Philips Medical Systems, Inc. · 2003
- 10 generations backK031481 The Philips Intellivue MP60, MP70, and MP90 Patient Monitors…Philips Medizin Systeme Boblingen GmbH · 2003
- 9 generations backK032858 The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient…Philips Medizin Systeme Boblingen GmbH · 2003
- 8 generations backK040304 Philips Intellivue Patient Monitor, Models MP40 & MP50Philips Medizin Systeme Boeblingen GmbH · 2004
- 7 generations backK041235 Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2004
- 6 generations backK042845 The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2004
- 5 generations backK050141 The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue…Philips Medizin Systeme Boeblingen GmbH · 2005
- 4 generations backK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
- 3 generations backK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005
- 2 generations backK052801 Intellivue Patient Monitors with Release C.02, Models MP20, MP30…Philips Medizin Systeme Boeblingen GmbH · 2005
- 1 generation backK053522 Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient…Philips Medizin Systeme Boeblingen GmbH · 2006
- This deviceK060221 The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90…Philips Medizin Systeme Boeblingen GmbH · 2006
Showing 5 of 222 descendants. See all descendants
Descendants cleared per year
2006high 21 (2023) · low 3 (2007)2026
Most influential descendants
Showing 5 of 222 · See all- K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2006 · cites it directly221descendants
- K061052The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90Philips Medical Systems North America, Inc. · 2006 · cites it directly211descendants
- K062283The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient MonitorsPhilips Medical Systems North America, Inc. · 2006 · cites it directly188descendants
- K062392Philips MP5 Intellivue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH · 2006 · cites it directly176descendants
- K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · 2 generations on175descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −19 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −18 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −17 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −16 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −15 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −14 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −13 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| −12 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
| −11 | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology… | Philips Medical Systems, Inc. | 2003 | — |
| −10 | K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release a.20 | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −9 | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors… | Philips Medizin Systeme Boblingen GmbH | 2003 | — |
| −8 | K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50 | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −7 | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient Monitors | Philips Medizin Systeme Boeblingen GmbH | 2004 | — |
| −6 | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient… | Philips Medizin Systeme Boblingen GmbH | 2004 | — |
| −5 | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −4 | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −3 | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −2 | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50… | Philips Medizin Systeme Boeblingen GmbH | 2005 | — |
| −1 | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| 0 (this device) | K060221 | The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| +1 | K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient… | Philips Medizin Systeme Boblingen GmbH | 2006 | 2 |
| +1 | K061052 | The Philips Intellivue Patient Monitors, Models… | Philips Medical Systems North America, Inc. | 2006 | — |
| +1 | K062283 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient… | Philips Medical Systems North America, Inc. | 2006 | — |
| +1 | K062392 | Philips MP5 Intellivue Patient Monitor | Philips Medizin Systeme Boeblingen GmbH | 2006 | — |
| +2 | K063725 | MP5 Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 5 | 0 |
| 1991 | 6 | 0 |
| 1992 | 6 | 0 |
| 1993 | 5 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 6 | 0 |
| 1997 | 6 | 0 |
| 1998 | 13 | 0 |
| 1999 | 9 | 0 |
| 2000 | 18 | 0 |
| 2001 | 5 | 0 |
| 2002 | 10 | 0 |
| 2003 | 6 | 0 |
| 2004 | 8 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 5 | 0 |
| 2011 | 8 | 0 |
| 2012 | 9 | 0 |
| 2013 | 11 | 0 |
| 2014 | 9 | 0 |
| 2015 | 7 | 0 |
| 2016 | 9 | 0 |
| 2017 | 11 | 0 |
| 2018 | 13 | 0 |
| 2019 | 9 | 0 |
| 2020 | 9 | 0 |
| 2021 | 13 | 0 |
| 2022 | 18 | 0 |
| 2023 | 21 | 0 |
| 2024 | 18 | 0 |
| 2025 | 21 | 0 |
| 2026 | 13 | 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 MHX? 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (16)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K014159 | Phillips M1175A/76A/77A Component Monitoring System; Phillips V24/V26 Patient MonitorSummary page 2…devices are substantially equivalent to previously cleared Philips devices marketed pursuant to and K014159, K021778, K030038, K032858, K040304, K040183 K042845, K050141, 050762 andc K040357, K041235,… | 2002 |
| * | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275BSummary page 2…are substantially equivalent to previously cleared Philips devices marketed pursuant to and K014159, K021778, K030038, K032858, K040304, K040183 K042845, K050141, 050762 andc K040357, K041235, K41741,… | 2002 |
| * | K030038 | Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185…Summary page 2…antially equivalent to previously cleared Philips devices marketed pursuant to and K014159, K021778, K030038, K032858, K040304, K040183 K042845, K050141, 050762 andc K040357, K041235, K41741, K051… | 2003 |
| * | K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O.Summary page 2…equivalent to previously cleared Philips devices marketed pursuant to and K014159, K021778, K030038, K032858, K040304, K040183 K042845, K050141, 050762 andc K040357, K041235, K41741, K051106, K052… | 2003 |
| * | K040304 | Philips Intellivue Patient Monitor, Models MP40 & MP50Summary page 2…t to previously cleared Philips devices marketed pursuant to and K014159, K021778, K030038, K032858, K040304, K040183 K042845, K050141, 050762 andc K040357, K041235, K41741, K051106, K052801 , K05… | 2004 |
| * | K040183 | BISXSummary page 2…previously cleared Philips devices marketed pursuant to and K014159, K021778, K030038, K032858, K040304, K040183 K042845, K050141, 050762 andc K040357, K041235, K41741, K051106, K052801 , K053522, and… | 2004 |
| * | K040357 | M3290A Intellivue Information Center Software Release F.O and the M4840A Telemetry…Summary page 2…and K014159, K021778, K030038, K032858, K040304, K040183 K042845, K050141, 050762 andc K040357, K041235, K41741, K051106, K052801 , K053522, and to Respironics Novametrix… | 2004 |
| * | K041235 | Philips MP20, MP30, MP40, MP50. MP60, MP70 and MP90 Intellivue Patient MonitorsSummary page 2…and K014159, K021778, K030038, K032858, K040304, K040183 K042845, K050141, 050762 andc K040357, K041235, K41741, K051106, K052801 , K053522, and to Respironics Novametrix… | 2004 |
| Kept off the family tree | K041741 | FDA’s K041741 is M3290A Intellivue Information Center Software Release F.0 and M4840A Philips… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
| * | K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsSummary page 2…keted pursuant to and K014159, K021778, K030038, K032858, K040304, K040183 K042845, K050141, 050762 andc K040357, K041235, K41741, K051106, K052801 , K053522, and to Respironics Novametrix… | 2004 |
| * | K050141 | The Philips MP20, MP30, MP40, MP50, MP60, MP70 and MP90 Intellivue Patient MonitorsSummary page 2…suant to and K014159, K021778, K030038, K032858, K040304, K040183 K042845, K050141, 050762 andc K040357, K041235, K41741, K051106, K052801 , K053522, and to Respironics Novametrix… | 2005 |
| * | K050762 | Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Summary page 2…and K014159, K021778, K030038, K032858, K040304, K040183 K042845, K050141, 050762 andc K040357, K041235, K41741, K051106, K052801 , K053522, and to Respironics Novametrix… | 2005 |
| * | K051106 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsSummary page 2…and K014159, K021778, K030038, K032858, K040304, K040183 K042845, K050141, 050762 andc K040357, K041235, K41741, K051106, K052801 , K053522, and to Respironics Novametrix 3468- LoFlo CS C… | 2005 |
| * | K052801 | Intellivue Patient Monitors with Release C.02, Models MP20, MP30, MP40, MP50, MP60…Summary page 2…and K014159, K021778, K030038, K032858, K040304, K040183 K042845, K050141, 050762 andc K040357, K041235, K41741, K051106, K052801 , K053522, and to Respironics Novametrix 3468- LoFlo CS C02 Sensor… | 2005 |
| * | K053522 | Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00Summary page 2…K014159, K021778, K030038, K032858, K040304, K040183 K042845, K050141, 050762 andc K040357, K041235, K41741, K051106, K052801 , K053522, and to Respironics Novametrix 3468- LoFlo CS C02 Sensor "PN102566… | 2006 |
| * | K053174 | Loflo C5 CO2 SensorSummary page 2…53522, and to Respironics Novametrix 3468- LoFlo CS C02 Sensor "PN1025669" and Accessories "PN 3475" (K053174) software 4. The modification is the introduction of Release D.02… | 2006 |
What descends from it? (222)
See all 22220 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors | 2006 | 221 |
| K061052 | The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 | 2006 | 211 |
| K062283 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient Monitors | 2006 | 188 |
| K062392 | Philips MP5 Intellivue Patient Monitor | 2006 | 176 |
| K061610 | Philips Model MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient… | 2006 | 155 |
| K063315 | Intellivue Patient Monitors, Models MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 | 2006 | 154 |
| K071426 | MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient… | 2007 | 151 |
| K082633 | Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50… | 2008 | 127 |
| K083517 | Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80… | 2009 | 125 |
| K091927 | Intellivue Patient Monitors ,Models MP40, MP50, MP60, MP70, MP80, MP90 | 2009 | 124 |
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 12 years and passes through 6 companies; a new generation was cleared every 4 months on median.
- 14 of the 133 ancestors have a recall of any class.
- Of its descendants, K060541 (Philips Medizin Systeme Boblingen GmbH, 2006) has gone furthest, with 221 descendants of its own.
- 9 other devices also cite its predicate K014159.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MHX
8in 2025
2007high 21 (2013) · low 5 (2021)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
2007high 248 (2014) · low 57 (2009)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
2007high 21 (2026) · low 0 (2020)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
2007high 3,761 (2025) · low 131 (2007)2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare facilities. The MP20, MP30, MP40 and MP50 are additionally intended for use in transport situations within healthcare facilities.
ST Segment monitoring is restricted to adult patients only.
The transcutaneous gas measurement (tcp0 2 / tcpC0 2) is restricted¢ to neonatal patients only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060221: The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient Monitors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060221
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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