510(k) · Cleared
Recalled · 2003Dinamap Pro Series Monitor, Models 110, 210, 310, 410
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Feb 1, 2002 as substantially equivalent to K992638 (Critikon Company, LLC, 2000) and 2 other predicates after a 29-day review. Its family tree reaches back 4 generations to 1997. 1 later device descends from it. It has been recalled once.
- Decided
- Feb 1, 2002
- Review
- 29 days
- Class
- Class II
- Product code
- MWI
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 4 generations to K962603 (1997). 19 ancestors in all, the oldest K896030 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 3 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 2 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 1 generation backK992238 Masimo Set Radical Pulse Oximeter, Lnop-Adt, Lnop-PDT, Lnop-Neo…Masimo Corp. · 1999
- This deviceK020022 Dinamap Pro Series Monitor, Models 110, 210, 310, 410Ge Medical Systems Information Technologies · 2002
- Descendant · cites it directly · 0 of its ownK021435 Dinamap Pro Series Monitor, Models 110N,210N,310N,410NGe Medical Systems Information Technologies · 2002 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K021435Dinamap Pro Series Monitor, Models 110N,210N,310N,410NGe Medical Systems Information Technologies · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −3 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −2 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −1 | K992238 | Masimo Set Radical Pulse Oximeter, Lnop-Adt, Lnop-PDT, Lnop-Neo, Lnop-Neo PT… | Masimo Corp. | 1999 | — |
| 0 (this device) | K020022 | Dinamap Pro Series Monitor, Models 110, 210, 310, 410 | Ge Medical Systems Information Technologies | 2002 | — |
| +1 | K021435 | Dinamap Pro Series Monitor, Models 110N,210N,310N,410N | Ge Medical Systems Information Technologies | 2002 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K992638 | Dinamap Pro Series Monitor, Models 100, 200, 300, 400Summary page 1…DPZ 870.2710 Thermometer, Clinical Electronic FLL 880.2910 Recorder, Paper Chart DSF 870.2810 D. Predicate/Legally Marketed Devices DINAMAP® Pro Series Monitor 100-400-K992638 Critikon Company, LLC E. Device Description The DINAMAP Pro Series 110-410 Monitor is a prescription device intended for use on… | 2000 |
| * | K992238 | Masimo Set Radical Pulse Oximeter, Lnop-Adt, Lnop-PDT, Lnop-Neo, Lnop-Neo PT, Lnop-Dci…Summary page 2…rical Safety K. Substantial Equivalence Pro Series 110-410 | Predicate Device & Model 510(k) Numbers Monitor DINAMAP Pro Series 100-400 | K992638 Pulse Oximetry Masimo K992238 Temperature Alaris Medical System K955846 NIBP DINAMAP Pro 1000 K002248 Page 2 of 2 00014 Public Health Service… | 1999 |
| Kept off the family tree | K955846 | FDA’s K955846 is Model 2082 Temp Plus Iii Thermometer/Model 2087 Temp Plus Iii Wall Mount… Our OCR of the scanned summary read K955846, FDA’s number for Model 2082 Temp Plus Iii Thermometer/Model 2087 Temp Plus… (Y). Its FDA name has none of the distinctive words the summary uses for the device it names, “Alaris Medical System”. Kept off the family tree. Summary page 2…Pro Series 110-410 | Predicate Device & Model 510(k) Numbers Monitor DINAMAP Pro Series 100-400 | K992638 Pulse Oximetry Masimo K992238 Temperature Alaris Medical System K955846 NIBP DINAMAP Pro 1000 K002248 Page 2 of 2 00014 Public Health Service Food and Drug Administration 9200 Corpora… | 1996 |
| * | K002248 | Dinamap Pro 1000 Monitor, Model 1000Summary page 2…Device & Model 510(k) Numbers Monitor DINAMAP Pro Series 100-400 | K992638 Pulse Oximetry Masimo K992238 Temperature Alaris Medical System K955846 NIBP DINAMAP Pro 1000 K002248 Page 2 of 2 00014 Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 2085… | 2000 |
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 |
|---|---|---|---|
| K021435 | Dinamap Pro Series Monitor, Models 110N,210N,310N,410N | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 30, 2003 | Not classified | Z-0011-04 | Component design/selection | Reports of broken plug ground pins on AC power cords for patient monitors. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K021435 (Ge Medical Systems Information Technologies, 2002) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K992638.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The DINAMAP® Pro Series 110-410 Monitor is intended to monitor a single adult, pediatric or neonatal patient’s vital signs at the bedside or during intra-hospital transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate and/or temperature and/or oxygen saturation (pulse oximetry). The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor and delivery, endoscopy, cardiac step-down. It can also be used in satellite areas, physicians’ offices, or alternate care settings.
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/K020022 · printed Nov 3, 2026
Cite this page
510(k) Report. “K020022: Dinamap Pro Series Monitor, Models 110, 210, 310, 410.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020022
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