510(k) · Cleared
Recalled · 2003Dinamap Pro Series Monitor, Models 110N,210N,310N,410N
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 May 22, 2002 as substantially equivalent to K020022 (Ge Medical Systems Information Technologies, 2002) and 1 other predicate after a 16-day review. Its family tree reaches back 5 generations to 1997. It has been recalled once.
- Decided
- May 22, 2002
- Review
- 16 days
- Class
- Class II
- Product code
- MWI
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K962603 (1997). 27 ancestors in all, the oldest K896030 (1989). No later device cites it as a predicate yet.
- Root · 5 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 4 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 3 generations backK990966 Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric…Masimo Corp. · 1999
- 2 generations backK992238 Masimo Set Radical Pulse Oximeter, Lnop-Adt, Lnop-PDT, Lnop-Neo…Masimo Corp. · 1999
- 1 generation backK020022 Dinamap Pro Series Monitor, Models 110, 210, 310, 410Ge Medical Systems Information Technologies · 2002 · Recalled
- This deviceK021435 Dinamap Pro Series Monitor, Models 110N,210N,310N,410NGe Medical Systems Information Technologies · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −4 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −3 | K990966 | Masimo Set 2000 Pulse Oximeter, Masimo Lnop -Adt-Adult/Pediatric Disposable… | Masimo Corp. | 1999 | — |
| −2 | K992238 | Masimo Set Radical Pulse Oximeter, Lnop-Adt, Lnop-PDT, Lnop-Neo, Lnop-Neo PT… | Masimo Corp. | 1999 | — |
| −1 | K020022 | Dinamap Pro Series Monitor, Models 110, 210, 310, 410 | Ge Medical Systems Information Technologies | 2002 | 1 |
| 0 (this device) | K021435 | Dinamap Pro Series Monitor, Models 110N,210N,310N,410N | Ge Medical Systems Information Technologies | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K020022 | Dinamap Pro Series Monitor, Models 110, 210, 310, 410Summary page 1…710 Thermometer, Clinical Electronic FLL 880.2910 Recorder, Paper Chart DSF - 870.2810 3 D. Predicate/Legally Marketed Devices E. DINAMAP® Pro Series Monitor 110-410-K020022 GE Medical Systems Information Technologies Device Description The DINAMAP Pro Series 110N-410N Monitor is a prescription devic… | 2002 |
| * | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables…Summary page 2…uivalence Pro Series 110N-410N | Predicate Device & Model 510(k) o o Numbers Monitor DINAMAP Pro Series 110-410 | K020022 Pulse Oximetry Nellcor N-595 Pulse Oximeter | K012891 Temperature Alaris Medical System K955846 NIBP: DINAMAP Pro Series 110-410 | K020022 Page 2 of 2 0037 -./é DEPA… | 2002 |
| 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…e Device & Model 510(k) o o Numbers Monitor DINAMAP Pro Series 110-410 | K020022 Pulse Oximetry Nellcor N-595 Pulse Oximeter | K012891 Temperature Alaris Medical System K955846 NIBP: DINAMAP Pro Series 110-410 | K020022 Page 2 of 2 0037 -./é DEPARTMENT OF HEALTH & HUMAN SERVICES . _ Publ… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 months on median.
- 5 of the 27 ancestors have a recall of any class.
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 110N-410N 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/K021435 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021435: Dinamap Pro Series Monitor, Models 110N,210N,310N,410N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021435
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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