510(k) · Cleared
ClearedSigma 8000 and Sigma 8002
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sigma Intl. General Medical Apparatus, Inc. · FRN Pump, Infusion
Cleared on Mar 22, 1995 after a 33-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 of the 37 devices in its family, counting itself, have a Class I recall. 36 later devices descend from it.
- Decided
- Mar 22, 1995
- Review
- 33 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 0
36 later devices descend from it, 4 citing it directly. 10 of the 37 devices in this family, counting this one, have a Class I recall.
- This deviceK950766 Sigma 8000 and Sigma 8002Sigma Intl. General Medical Apparatus, Inc. · 1995
- Descendant · cites it directly · 28 of its ownK042121 Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · Recalled (Class I)
- Descendant · 2 generations on · 18 of its ownK133801 Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · Recalled (Class I)
- Descendant · 3 generations on · 9 of its ownK173084 Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018 · Recalled (Class I)
- Descendant · 2 generations on · 7 of its ownK123049 Sapphire Infusion PumpQ Core Medical, Ltd. · 2013
- Descendant · 3 generations on · 5 of its ownK142374 ivWatch Model 400Ivwatch, LLC · 2015
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 36 · See all- K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · cites it directly28descendants
- K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · 2 generations on18descendants
- K173084Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018 · 3 generations on9descendants
- K123049Sapphire Infusion PumpQ Core Medical, Ltd. · 2013 · 2 generations on7descendants
- K142374ivWatch Model 400Ivwatch, LLC · 2015 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950766 | Sigma 8000 and Sigma 8002 | Sigma Intl. General Medical Apparatus, Inc. | 1995 | — |
| +1 | K042121 | Spectrum and Spectrum with Master Drug Library | Sigma Intl. | 2004 | Class I |
| +2 | K133801 | Baxter Sigma Spectrum Infusion Pump with Master Drug Library | Baxter Healthcare Corporation | 2014 | Class I |
| +3 | K173084 | Spectrum IQ Infusion System, Dose IQ Safety Software | Baxter Healthcare Corporation | 2018 | Class I |
| +2 | K123049 | Sapphire Infusion Pump | Q Core Medical, Ltd. | 2013 | — |
| +3 | K142374 | ivWatch Model 400 | Ivwatch, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 1 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 1 |
| 2013 | 2 | 1 |
| 2014 | 4 | 1 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 1 |
| 2019 | 1 | 1 |
| 2020 | 2 | 1 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 2 |
| 2024 | 3 | 1 |
| 2025 | 2 | 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.
10 devices in this family have a Class I recall. 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 FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (36)
See all 364 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (10 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K042121Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 13 Class I recalls
- K100705Zyno Z-800 Infusion System Model Z-800Zyno Medical, LLC · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 15 Class I recalls
- K133801Baxter Sigma Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2014 · 2 generations on · ◆ in the 2014 descendants bar of FIG. 15 Class I recalls
- K130690Z-800 Infusion SystemZyno Medical, LLC · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 15 Class I recalls
- K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K230022Baxter SIGMA Spectrum Infusion Pump with Master Drug LibraryBaxter Healthcare Corporation · 2023 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
- K173084Spectrum IQ Infusion System, Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2018 · 3 generations on · ◆ in the 2018 descendants bar of FIG. 14 Class I recalls
- K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 113 Class I recalls
- K211122Novum IQ Large Volume PumpBaxter Healthcare Corporation · 2024 · 4 generations on · ◆ in the 2024 descendants bar of FIG. 13 Class I recalls
- K230041Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation · 2023 · 6 generations on · ◆ in the 2023 descendants bar of FIG. 12 Class I recalls
Nearest 5 of 10; all are on the web page.
What does this lineage say?
- Of its descendants, K042121 (Sigma Intl., 2004) has gone furthest, with 28 descendants of its own.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, 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 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
https://510kreport.com/device/K950766 · printed Nov 4, 2026
Cite this page
510(k) Report. “K950766: Sigma 8000 and Sigma 8002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950766
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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