510(k) · Cleared
ClearedFogg System Patient Monitoring Cables
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fogg System Company, Inc. · DSA Cable, Transducer And Electrode, Patient, (Including Connector)
Cleared on Nov 22, 2023 as substantially equivalent to K203635 (Jkh USA, LLC, 2021) after a 440-day review. Its family tree reaches back 11 generations to 1994.
- Decided
- Nov 22, 2023
- Review
- 440 days
- Class
- Class II
- Product code
- DSA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K941811 (1994). 40 ancestors in all, the oldest K872781 (1987). No later device cites it as a predicate yet.
- Root · 11 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 7 generations between
- 3 generations backK110287 Philips Ecg Leadwire SetPhilips Medical Systems · 2011 · Recalled
- 2 generations backK142489 Unimed Disposable ECG lead wiresUnimed Medical Supplies, Inc. · 2014
- 1 generation backK203635 Patient Monitoring CablesJkh USA, LLC · 2021
- This deviceK222712 Fogg System Patient Monitoring CablesFogg System Company, Inc. · 2023
Show all 11 generations
- Root · 11 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 10 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 9 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 8 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 7 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 6 generations backK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- 5 generations backK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- 4 generations backK102430 Tyco Electronics Electrocardiograph (Ecg) Leadwire SetTyco Electronics Corporation · 2010
- 3 generations backK110287 Philips Ecg Leadwire SetPhilips Medical Systems · 2011 · Recalled
- 2 generations backK142489 Unimed Disposable ECG lead wiresUnimed Medical Supplies, Inc. · 2014
- 1 generation backK203635 Patient Monitoring CablesJkh USA, LLC · 2021
- This deviceK222712 Fogg System Patient Monitoring CablesFogg System Company, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −10 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −9 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −8 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −7 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −6 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| −5 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| −4 | K102430 | Tyco Electronics Electrocardiograph (Ecg) Leadwire Set | Tyco Electronics Corporation | 2010 | — |
| −3 | K110287 | Philips Ecg Leadwire Set | Philips Medical Systems | 2011 | 1 |
| −2 | K142489 | Unimed Disposable ECG lead wires | Unimed Medical Supplies, Inc. | 2014 | — |
| −1 | K203635 | Patient Monitoring Cables | Jkh USA, LLC | 2021 | — |
| 0 (this device) | K222712 | Fogg System Patient Monitoring Cables | Fogg System Company, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 8 | 0 |
| 2008 | 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 DSA? 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 DSA device
- #1 K252827 IBP cable Becton Dickinson (2606488); IBP…score 11.3 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K203635 | Patient Monitoring CablesSummary page 4…by both the subject and predicate devices. Table 1 Substantial Equivalence Table Description Subject Device Predicate Device (K203635) Device Name Patient Monitoring Cables Patient Monitoring Cables The Patient… | 2021 |
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 29 years and passes through 8 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 40 ancestors have a recall of any class.
- 1 other device also cites its predicate K203635.
How does its category compare?
All DSA devicesDSA Cable, Transducer And Electrode, Patient, (Including Connector): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · DSA
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DSA
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DSA
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DSA
67in 2025
MAUDE reports naming product code DSA, 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 | 2 | — | 0 | 4 |
| 2008 | 6 | 59 | 0 | 11 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 4 | 55 | 2 | 1 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 1 | — | 0 | 23 |
| 2014 | 1 | — | 0 | 67 |
| 2015 | 0 | — | 0 | 34 |
| 2016 | 2 | — | 0 | 28 |
| 2017 | 5 | 140 | 0 | 5 |
| 2018 | 3 | 84 | 0 | 16 |
| 2019 | 4 | 140 | 0 | 11 |
| 2020 | 6 | 177 | 0 | 31 |
| 2021 | 4 | 164 | 0 | 7 |
| 2022 | 2 | — | 1 | 49 |
| 2023 | 3 | 240 | 0 | 29 |
| 2024 | 3 | 102 | 0 | 40 |
| 2025 | 4 | 105 | 0 | 67 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Patient Monitoring Cables are intended to be used with SpO2, Temperature, BP, ECG, Cardiac Output, and related monitoring devices. The Patient Monitoring Cables are used to connect electrodes, catheters, and/or sensors placed at appropriate sites on the patient to a monitoring device, or between monitoring devices, for general monitoring and/or diagnostic evaluation by health care professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222712 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222712: Fogg System Patient Monitoring Cables.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222712
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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