510(k) · Cleared
Recalled · Class II · 2020Bodyguard Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caesarea Medical Electronics, Ltd. · FRN Pump, Infusion
Cleared on Aug 21, 2003 after a 77-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 10 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it. It has been recalled once.
- Decided
- Aug 21, 2003
- Review
- 77 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 1
- Predicates
- 0
9 later devices descend from it, 2 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- This deviceK031749 Bodyguard Infusion SystemCaesarea Medical Electronics, Ltd. · 2003
- Descendant · cites it directly · 8 of its ownK082182 AP 34 Multi-Therapy Infusion PumpQ-Core, Ltd. · 2008
- Descendant · 2 generations on · 7 of its ownK123049 Sapphire Infusion PumpQ Core Medical, Ltd. · 2013
- Descendant · 3 generations on · 3 of its ownK141389 Sapphire Infusion PumpQ Core Medical, Ltd. · 2014
- Descendant · 4 generations on · 2 of its ownK161667 Sapphire Infusion PumpQ Core Medical, Ltd. · 2017
- Descendant · 3 generations on · 1 of its ownK192860 Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · Recalled (Class I)
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K192860 Sapphire Infusion Pump, Sapphire administration…3 generations on · 2020
Most influential descendants
Showing 5 of 9 · See all- K082182AP 34 Multi-Therapy Infusion PumpQ-Core, Ltd. · 2008 · cites it directly8descendants
- K123049Sapphire Infusion PumpQ Core Medical, Ltd. · 2013 · 2 generations on7descendants
- K141389Sapphire Infusion PumpQ Core Medical, Ltd. · 2014 · 3 generations on3descendants
- K161667Sapphire Infusion PumpQ Core Medical, Ltd. · 2017 · 4 generations on2descendants
- K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031749 | Bodyguard Infusion System | Caesarea Medical Electronics, Ltd. | 2003 | — |
| +1 | K082182 | AP 34 Multi-Therapy Infusion Pump | Q-Core, Ltd. | 2008 | — |
| +2 | K123049 | Sapphire Infusion Pump | Q Core Medical, Ltd. | 2013 | — |
| +3 | K141389 | Sapphire Infusion Pump | Q Core Medical, Ltd. | 2014 | — |
| +4 | K161667 | Sapphire Infusion Pump | Q Core Medical, Ltd. | 2017 | — |
| +3 | K192860 | Sapphire Infusion Pump, Sapphire administration sets | Q Core Medical, Ltd. | 2020 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 1 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 14, 2020 | Class II | Z-1886-2020 | Process control | The filter installed onto the tube set may have the incorrect pore size. |
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.
- K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K082182 (Q-Core, Ltd., 2008) has gone furthest, with 8 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) | — |
What is it indicated for?
The BodyGucrrd Infusion system is designed to transfer medication and fluids intravenously. The system is intended for patients who require maintenance medications, PCA therapy, Parenteral nutritional fluids and general I.V. fluids therapy in hospital and home care environments.
The BodyGuul-d Infusion system includes:
Infusion Pump
Battery Charger
Infusion Sets (Microset/ BodySet female luer)
PCA cable (optional)
Charging cable (optional)
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K031749 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031749: Bodyguard Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031749
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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