510(k) · Cleared
ClearedZyter RPM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zyter, Inc. · MSX System, Network And Communication, Physiological Monitors
Cleared on Feb 11, 2022 as substantially equivalent to K193421 (Boxview, LLC, 2020) and 1 other predicate after a 177-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Feb 11, 2022
- Review
- 177 days
- Class
- Class II
- Product code
- MSX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K962827 (1997). 24 ancestors in all, the oldest K913193 (1991). No later device cites it as a predicate yet.
- Root · 8 generations backK962827 Alarm Display Unit/Pager-Lan System (Adu)Marquette Electronics, Inc. · 1997
- 7 generations backK971868 Impact (Informing Mobile Personnel and Care Tracking) Pager SystemMarquette Electronics, Inc. · 1997
- 6 generations backK973527 Cardio-Pager SystemData Critical Corp. · 1998
- 5 generations backK992749 Ultraview Waveform Pager System, Model 91841Spacelabs Medical, Inc. · 2000
- 4 generations backK062278 Spacelabs Medical Clinical Event Interface, Model 91847Spacelabs Medical, Inc. · 2006
- 3 generations backK103634 Ascom Clinicalconnex CardiomaxAscom (Us), Inc. · 2011
- 2 generations backK111215 Ascom Mobile Monitoring Gateway (MMG)Ascom (Sweden) AB · 2011 · Recalled
- 1 generation backK193421 Smart Alarm InterfaceBoxview, LLC · 2020
- This deviceK212622 Zyter RPMZyter, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962827 | Alarm Display Unit/Pager-Lan System (Adu) | Marquette Electronics, Inc. | 1997 | — |
| −7 | K971868 | Impact (Informing Mobile Personnel and Care Tracking) Pager System | Marquette Electronics, Inc. | 1997 | — |
| −6 | K973527 | Cardio-Pager System | Data Critical Corp. | 1998 | — |
| −5 | K992749 | Ultraview Waveform Pager System, Model 91841 | Spacelabs Medical, Inc. | 2000 | — |
| −4 | K062278 | Spacelabs Medical Clinical Event Interface, Model 91847 | Spacelabs Medical, Inc. | 2006 | — |
| −3 | K103634 | Ascom Clinicalconnex Cardiomax | Ascom (Us), Inc. | 2011 | — |
| −2 | K111215 | Ascom Mobile Monitoring Gateway (MMG) | Ascom (Sweden) AB | 2011 | 1 |
| −1 | K193421 | Smart Alarm Interface | Boxview, LLC | 2020 | — |
| 0 (this device) | K212622 | Zyter RPM | Zyter, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 MSX? 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 MSX device
- #1 K242750 Central Stationscore 21.5 · 31 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 |
|---|---|---|---|
| * | K193421 | Smart Alarm InterfaceSummary page 4…BoxView, LLC Primary Predicate Trade Name: BoxView Smart Alarm Interface (SAI), Model SA-01 Primary Predicate 510(k): K193421 Secondary Predicate Manufacturer: EARLYSENSE LTD. Secondary Predicate Trade Name: EarlyS… | 2020 |
| * | K151006 | EarlySense Central Display Station (CDS)Summary page 4…EARLYSENSE LTD. Secondary Predicate Trade Name: EarlySense Central Display Station (CDS) Secondary Predicate 510(k): K151006 No reference devices were used in this submission. IV. DEVICE DESCRIPTION Zyter RPM is a Software as a Medical Device (SaMD)… | 2015 |
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 25 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 24 ancestors have a recall of any class.
- 1 other device also cites its predicate K193421.
How does its category compare?
All MSX devicesMSX System, Network And Communication, Physiological Monitors: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · MSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSX
295in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSX
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSX
19in 2025
MAUDE reports naming product code MSX, 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 | 4 | 58 | 1 | 5 |
| 2008 | 1 | — | 1 | 6 |
| 2009 | 1 | — | 2 | 7 |
| 2010 | 3 | 43 | 1 | 14 |
| 2011 | 7 | 72 | 1 | 3 |
| 2012 | 4 | 145 | 2 | 4 |
| 2013 | 2 | — | 0 | 17 |
| 2014 | 3 | 165 | 0 | 32 |
| 2015 | 5 | 138 | 2 | 31 |
| 2016 | 3 | 174 | 0 | 11 |
| 2017 | 2 | — | 2 | 16 |
| 2018 | 4 | 111 | 1 | 15 |
| 2019 | 4 | 92 | 0 | 15 |
| 2020 | 5 | 193 | 0 | 25 |
| 2021 | 3 | 227 | 0 | 17 |
| 2022 | 5 | 177 | 1 | 18 |
| 2023 | 3 | 244 | 0 | 10 |
| 2024 | 4 | 212 | 0 | 32 |
| 2025 | 4 | 295 | 1 | 19 |
| 2026 | 5 | 145 | 2 | — |
What is it indicated for?
The intended use of the Zyter RPM is to provide an interface with physiological patient monitoring systems to forward recorded device information to the patient’s healthcare provider.
Zyter RPM does not alter the behavior of the primary medical devices and associated alert annunciations.
Zyter RPM is not intended to be used for diagnostic purposes. Zyter RPM is intended for use by professional clinical personnel and relies on proper use and operation of both the communication infrastructure in place at the use environment (e.g., healthcare facility or home setting) and the display interface used. Zyter RPM is a software product and cannot come into physical contact with patients.
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/K212622 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212622: Zyter RPM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212622
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