510(k) · Cleared
ClearedHospira Sapphire Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospira, Inc. · MRZ Accessories, Pump, Infusion
Cleared on Dec 6, 2016 as substantially equivalent to K123049 (Q Core Medical, Ltd., 2013) after a 288-day review. Its family tree reaches back 5 generations to 1990. 3 of the 17 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 6, 2016
- Review
- 288 days
- Class
- Class II
- Product code
- MRZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K904518 (1990). 16 ancestors in all. No later device cites it as a predicate yet. 3 of the 17 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 4 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 3 generations backK011975 Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Recalled (Class I)
- 2 generations backK042121 Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · Recalled (Class I)
- 1 generation backK123049 Sapphire Infusion PumpQ Core Medical, Ltd. · 2013
- This deviceK160492 Hospira Sapphire SetsHospira, Inc. · 2016
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −4 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −3 | K011975 | Horizon Outlook with Dosecom | B.Braun Medical, Inc. | 2001 | Class I |
| −2 | K042121 | Spectrum and Spectrum with Master Drug Library | Sigma Intl. | 2004 | Class I |
| −1 | K123049 | Sapphire Infusion Pump | Q Core Medical, Ltd. | 2013 | — |
| 0 (this device) | K160492 | Hospira Sapphire Sets | Hospira, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 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.
3 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 MRZ device
- #1 K193654 BlueStar Rxscore 7.5 · 9 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 |
|---|---|---|---|
| * | K123049 | Sapphire Infusion PumpSummary page 4…ion name Infusion Pump, 21 CFR 880.5725, Class II Product Code(s) MRZ Legally marketed device(s) to which Q Core Medical Sapphire Sets – K123049 (Predicate 510(k)) equivalence is claimed Hospira Plum Sets – K141789 (reference 510(k) for technological characte… | 2013 |
| † | K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for… | 2015 |
| † | K043256 | Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca Infusion System… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 3.1 years on median.
- 9 of the 16 ancestors have a recall of any class; 3 have a Class I recall.
- 4 other devices also cite its predicate K123049.
How does its category compare?
All MRZ devicesMRZ Accessories, Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · MRZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MRZ
96in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRZ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRZ
35in 2025
MAUDE reports naming product code MRZ, 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 | 0 |
| 2008 | 4 | 96 | 0 | 0 |
| 2009 | 2 | — | 1 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 117 |
| 2016 | 2 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 18 |
| 2018 | 1 | — | 1 | 46 |
| 2019 | 1 | — | 5 | 36 |
| 2020 | 2 | — | 0 | 44 |
| 2021 | 1 | — | 0 | 61 |
| 2022 | 1 | — | 0 | 39 |
| 2023 | 1 | — | 0 | 27 |
| 2024 | 0 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Hospira Sapphire sets are indicated for the delivery of fluids from a container to a patient’s vascular system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160492 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160492: Hospira Sapphire Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160492
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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