510(k) · Cleared
ClearedAP 34 Multi-Therapy Infusion Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Q-Core, Ltd. · FRN Pump, Infusion
Cleared on Aug 15, 2008 as substantially equivalent to K960826 (Sims Deltec, Inc., 1996) and 2 other predicates after a 14-day review. Its family tree reaches back 2 generations to 2002. 1 of the 13 devices in its family, counting itself, has a Class I recall. 8 later devices descend from it.
- Decided
- Aug 15, 2008
- Review
- 14 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K021480 (2002). 4 ancestors in all, the oldest K960826 (1996). 8 later devices descend from it, 1 citing it directly. 1 of the 13 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK021480 Extension Set Light-Safe, Model BC565Codan US Corp. · 2002
- 1 generation backK041490 IV Administration Sets with Ultrablock UV-Resistant TubingB.Braun Medical, Inc. · 2004 · Recalled
- This deviceK082182 AP 34 Multi-Therapy Infusion PumpQ-Core, Ltd. · 2008
- Descendant · cites it directly · 7 of its ownK123049 Sapphire Infusion PumpQ Core Medical, Ltd. · 2013
- Descendant · 2 generations on · 3 of its ownK141389 Sapphire Infusion PumpQ Core Medical, Ltd. · 2014
- Descendant · 3 generations on · 2 of its ownK161667 Sapphire Infusion PumpQ Core Medical, Ltd. · 2017
- Descendant · 2 generations on · 1 of its ownK192860 Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK213744 Avoset Infusion Pump SystemEitan Medical, Ltd. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K192860 Sapphire Infusion Pump, Sapphire administration…2 generations on · 2020
Most influential descendants
Showing 5 of 8 · See all- K123049Sapphire Infusion PumpQ Core Medical, Ltd. · 2013 · cites it directly7descendants
- K141389Sapphire Infusion PumpQ Core Medical, Ltd. · 2014 · 2 generations on3descendants
- K161667Sapphire Infusion PumpQ Core Medical, Ltd. · 2017 · 3 generations on2descendants
- K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · 2 generations on1descendant
- K213744Avoset Infusion Pump SystemEitan Medical, Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021480 | Extension Set Light-Safe, Model BC565 | Codan US Corp. | 2002 | — |
| −1 | K041490 | IV Administration Sets with Ultrablock UV-Resistant Tubing | B.Braun Medical, Inc. | 2004 | 1 |
| 0 (this device) | K082182 | AP 34 Multi-Therapy Infusion Pump | Q-Core, Ltd. | 2008 | — |
| +1 | K123049 | Sapphire Infusion Pump | Q Core Medical, Ltd. | 2013 | — |
| +2 | K141389 | Sapphire Infusion Pump | Q Core Medical, Ltd. | 2014 | — |
| +3 | K161667 | Sapphire Infusion Pump | Q Core Medical, Ltd. | 2017 | — |
| +2 | K192860 | Sapphire Infusion Pump, Sapphire administration sets | Q Core Medical, Ltd. | 2020 | Class I |
| +3 | K213744 | Avoset Infusion Pump System | Eitan Medical, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 summary (predicates and 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? (3)
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 |
|---|---|---|---|
| * | K960826 | Cadd-Prizm Model 6100 PumpSummary page 2…05022-100-0001 -PMP Part Numbers of AP 34 Sets 05060-520-OOOX-ASMM-0X Sec. 807.92(a}(3) Predicate Devices *CADD-Prizm Model 6100 (K960826) *Bodyguard Infusion System and infusion sets (Caes… | 1996 |
| * | K031749 | Bodyguard Infusion SystemSummary page 2…6100 (K960826) *Bodyguard Infusion System and infusion sets (Caesarea Medical Electronics - K031749) *IV Administration Sets with Ultrablock UV-resistant… | 2003 |
| * | K041490 | IV Administration Sets with Ultrablock UV-Resistant TubingSummary page 2…ics - K031749) *IV Administration Sets with Ultrablock UV-resistant tubing (B. Braun Inc. - K041490). Sec. 807.92(a)(4}: Device Description: The Q-CORE AP 34 multi-therapy Infusion Pump is a software driven, volumetric, ambulat… | 2004 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123049 | Sapphire Infusion Pump | 2013 | 7 |
Has anything in its family been recalled? (1 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.
- K192860Sapphire Infusion Pump, Sapphire administration setsQ Core Medical, Ltd. · 2020 · 2 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K123049 (Q Core Medical, Ltd., 2013) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K960826.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 AP 34 is a multi-therapy infusion pump system designed for the volumetric infusion of medication and nutritional fluids to patients in the hospital, homecare and outpatient environments in the following delivery modes: CONTINUOUS; INTERMITTENT; PCA (Patient Control Analgesia) and TPN (Total Parenteral Nutrition). The AP 34 is not intended for the following use or substances: * Delivery of blood or cellular blood products * Intra-cardiac use. The AP…
Read the full statement (134 words)
The AP 34 is a multi-therapy infusion pump system designed for the volumetric infusion of medication and nutritional fluids to patients in the hospital, homecare and outpatient environments in the following delivery modes: CONTINUOUS; INTERMITTENT; PCA (Patient Control Analgesia) and TPN (Total Parenteral Nutrition). The AP 34 is not intended for the following use or substances:
* Delivery of blood or cellular blood products
* Intra-cardiac use.
The AP 34 infusion pump includes the following accessories:
* Bolus cable
* 0Q--Core approved AC/DC adaptor (external)]
* Cradle (optional) and power cable for cradle
* Rechargeable battery pack for pump
* PCA cover box
* Communication cables
The dedicated Q-Core Administration Sets for the AP 34 infusion pump are intended for single-patient use only.
The AP 34 infusion pump system is for prescription use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082182: AP 34 Multi-Therapy Infusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082182
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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