510(k) · Cleared
ClearedHewlett-Packard Model M1018A TCPO2/TOPCO2 Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hewlett-Packard Co. · KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Cleared on Jul 29, 1993 after a 248-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 432 later devices descend from it.
- Decided
- Jul 29, 1993
- Review
- 248 days
- Class
- Class II
- Product code
- KLK
- Recalls
- None
- Predicates
- 0
432 later devices descend from it, 2 citing it directly.
- This deviceK925910 Hewlett-Packard Model M1018A TCPO2/TOPCO2 ModuleHewlett-Packard Co. · 1993
- Descendant · cites it directly · 431 of its ownK013199 Philips Component Compact Monitor,Model M1275B, Philips Compenent…Philips Medical Systems, Inc. · 2001
- Descendant · 2 generations on · 421 of its ownK021300 Modification of Philips Component Compact Monitor, Release a.03…Philips Medical Systems · 2002
- Descendant · 2 generations on · 416 of its ownK020531 Philips Multi-Parameter Module, Model M3001A; Philips Component…Philips Medical Systems · 2002
- Descendant · 2 generations on · 407 of its ownK021778 Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002
- Descendant · 3 generations on · 406 of its ownK023871 M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70…Philips Medical Systems · 2002
Showing 5 of 432 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 432 · See all- K013199Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model M1276BPhilips Medical Systems, Inc. · 2001 · cites it directly431descendants
- K021300Modification of Philips Component Compact Monitor, Release a.03, Model M1275BPhilips Medical Systems · 2002 · 2 generations on421descendants
- K020531Philips Multi-Parameter Module, Model M3001A; Philips Component Compact Monitor, Release…Philips Medical Systems · 2002 · 2 generations on416descendants
- K021778Philips Component Compact Monitor, Release a.04, Model #M1275BPhilips Medical Systems · 2002 · 2 generations on407descendants
- K023871M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue Patient…Philips Medical Systems · 2002 · 3 generations on406descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925910 | Hewlett-Packard Model M1018A TCPO2/TOPCO2 Module | Hewlett-Packard Co. | 1993 | — |
| +1 | K013199 | Philips Component Compact Monitor,Model M1275B, Philips Compenent Rack, Model… | Philips Medical Systems, Inc. | 2001 | — |
| +2 | K021300 | Modification of Philips Component Compact Monitor, Release a.03, Model M1275B | Philips Medical Systems | 2002 | — |
| +2 | K020531 | Philips Multi-Parameter Module, Model M3001A; Philips Component Compact… | Philips Medical Systems | 2002 | — |
| +2 | K021778 | Philips Component Compact Monitor, Release a.04, Model #M1275B | Philips Medical Systems | 2002 | — |
| +3 | K023871 | M3046A (M2/M3/M4) Compact Portable Patient Monitor and MP60 & MP70 Intellivue… | Philips Medical Systems | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 10 | 0 |
| 2005 | 10 | 0 |
| 2006 | 16 | 0 |
| 2007 | 7 | 0 |
| 2008 | 14 | 0 |
| 2009 | 19 | 0 |
| 2010 | 21 | 0 |
| 2011 | 21 | 0 |
| 2012 | 19 | 0 |
| 2013 | 17 | 0 |
| 2014 | 16 | 0 |
| 2015 | 14 | 0 |
| 2016 | 17 | 0 |
| 2017 | 17 | 0 |
| 2018 | 25 | 0 |
| 2019 | 17 | 0 |
| 2020 | 14 | 0 |
| 2021 | 19 | 0 |
| 2022 | 28 | 0 |
| 2023 | 27 | 0 |
| 2024 | 25 | 0 |
| 2025 | 29 | 0 |
| 2026 | 20 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KLK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (432)
See all 4322 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K013199 (Philips Medical Systems, Inc., 2001) has gone furthest, with 431 descendants of its own.
How does its category compare?
All KLK devicesKLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLK
FDA has decided no KLK device since 2007.
Median 510(k) review, days · KLK
Too few KLK 510(k)s in any year since 2007 to give a median.
Recalls per year · KLK
No recall names KLK since 2007.
Adverse event reports per year · KLK
1in 2022
MAUDE reports naming product code KLK, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K925910 · printed Nov 5, 2026
Cite this page
510(k) Report. “K925910: Hewlett-Packard Model M1018A TCPO2/TOPCO2 Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K925910
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026