510(k) · Cleared
ClearedSapphire Infusion Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Q Core Medical, Ltd. · FRN Pump, Infusion
Cleared on Oct 17, 2013 as substantially equivalent to K082182 (Q-Core, Ltd., 2008) and 3 other predicates after a 384-day review. Its family tree reaches back 4 generations to 1990. 4 of the 23 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it.
- Decided
- Oct 17, 2013
- Review
- 384 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K904518 (1990). 15 ancestors in all. 7 later devices descend from it, 5 citing it directly. 4 of the 23 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK904518 Volumetric Infusion PumpKendall Mcgaw Laboratories, Inc. · 1990 · Recalled
- 3 generations backK994375 Horizon LightB.Braun Medical, Inc. · 2000 · Recalled (Class I)
- 2 generations backK011975 Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · Recalled (Class I)
- 1 generation backK042121 Spectrum and Spectrum with Master Drug LibrarySigma Intl. · 2004 · Recalled (Class I)
- This deviceK123049 Sapphire Infusion PumpQ Core Medical, Ltd. · 2013
- Descendant · cites it directly · 3 of its ownK141389 Sapphire Infusion PumpQ Core Medical, Ltd. · 2014
- Descendant · 2 generations on · 2 of its ownK161667 Sapphire Infusion PumpQ Core Medical, Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK192860 Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK213744 Avoset Infusion Pump SystemEitan Medical, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK171346 Sapphire SetsIcu Medical · 2017 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K141389Sapphire Infusion PumpQ Core Medical, Ltd. · 2014 · cites it directly3descendants
- K161667Sapphire Infusion PumpQ Core Medical, Ltd. · 2017 · 2 generations on2descendants
- K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · cites it directly1descendant
- K213744Avoset Infusion Pump SystemEitan Medical, Ltd. · 2023 · 2 generations on0descendants
- K171346Sapphire SetsIcu Medical · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904518 | Volumetric Infusion Pump | Kendall Mcgaw Laboratories, Inc. | 1990 | 37 |
| −3 | K994375 | Horizon Light | B.Braun Medical, Inc. | 2000 | Class I |
| −2 | K011975 | Horizon Outlook with Dosecom | B.Braun Medical, Inc. | 2001 | Class I |
| −1 | K042121 | Spectrum and Spectrum with Master Drug Library | Sigma Intl. | 2004 | Class I |
| 0 (this device) | K123049 | Sapphire Infusion Pump | Q Core Medical, Ltd. | 2013 | — |
| +1 | K141389 | Sapphire Infusion Pump | Q Core Medical, Ltd. | 2014 | — |
| +2 | K161667 | Sapphire Infusion Pump | Q Core Medical, Ltd. | 2017 | — |
| +1 | K192860 | Sapphire Infusion Pump, Sapphire administration sets | Q Core Medical, Ltd. | 2020 | Class I |
| +2 | K213744 | Avoset Infusion Pump System | Eitan Medical, Ltd. | 2023 | — |
| +1 | K171346 | Sapphire Sets | Icu Medical | 2017 | 9 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 1 |
| 2023 | 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.
4 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? (4)
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 |
|---|---|---|---|
| * | K082182 | AP 34 Multi-Therapy Infusion PumpSummary page 1…(PCA) infusion pump MRZ - Infusion pump accessories (administration sets) Predicate Device AP34 Multi-therapy Infusion pump (K082 182) Infusion Pump Spectrum Infusion Pump with Master Drug Library (K04212 1), CADD-Pri… | 2008 |
| * | K042121 | Spectrum and Spectrum with Master Drug LibrarySummary page 1…istration sets) Predicate Device AP34 Multi-therapy Infusion pump (K082 182) Infusion Pump Spectrum Infusion Pump with Master Drug Library (K04212 1), CADD-Prizm Model 6101 Ambulatory Infusion Pump (K000842)… | 2004 |
| * | K000842 | Cadd-Prizm PCS II Model 6101 Ambulatory Infusion SystemSummary page 1…Spectrum Infusion Pump with Master Drug Library (K04212 1), CADD-Prizm Model 6101 Ambulatory Infusion Pump (K000842) Bodyguard Infusion Pump System (K060479) Administration Sets Q Core Administration Sets… | 2000 |
| * | K060479 | Modification to Bodyguard Infusion Pump SystemSummary page 1…CADD-Prizm Model 6101 Ambulatory Infusion Pump (K000842) Bodyguard Infusion Pump System (K060479) Administration Sets Q Core Administration Sets cleared under K082182 Device Description The Q Core Sapphire infusion… | 2006 |
What descends from it? (7)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (4 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 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
- K011975Horizon Outlook with DosecomB.Braun Medical, Inc. · 2001 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K994375Horizon LightB.Braun Medical, Inc. · 2000 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · Cites it directly · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 9.1 years on median.
- 9 of the 15 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K141389 (Q Core Medical, Ltd., 2014) has gone furthest, with 3 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. 2013, this device’s year, is highlighted.
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) | — |
What is it indicated for?
The Q Core Sapphire infusion pump is intended for the controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. The pump is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, IV medication, epidural medication, blood and blood products. The Sapphire pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural. The pump is intended to be…
Read the full statement (106 words)
The Q Core Sapphire infusion pump is intended for the controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. The pump is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, IV medication, epidural medication, blood and blood products.
The Sapphire pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural.
The pump is intended to be used by both licensed health care professionals in a clinical environment, and home users in an ambulatory environment and in pre-hospital medical ground transportation.
The dedicated Q Core administration sets for the Sapphire pump are intended for single-patient use and single-use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123049 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123049: Sapphire Infusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123049
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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