510(k) · Cleared
ClearedApoteca Dug Compounding Dosing Device,Apoteca I.V. Transfer Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Mar 21, 2014 as substantially equivalent to K110771 (Becton, Dickinson and Company, 2011) and 4 other predicates after a 263-day review. Its family tree reaches back 4 generations to 1988. 1 of the 11 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 21, 2014
- Review
- 263 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K883614 (1988). 10 ancestors in all, the oldest K832347 (1983). No later device cites it as a predicate yet. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK883614 Cytoguard (R)Survival Technology, Inc. · 1988
- 3 generations backK972527 Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting · 1997
- 2 generations backK980381 Phaseal, Closed System Forhandling of Parenteral Drugs, Additional…Carmel Pharma Ab. · 1998
- 1 generation backK071741 Tevadaptor, Closed Drug Reconstitution and Transfer SystemMigada Plant · 2007 · Recalled
- This deviceK132011 Apoteca Dug Compounding Dosing Device,Apoteca I.V. Transfer SetAea Srl · 2014
Class I recalls in this family
- K002705 Exacta-Mix 2400 Compounding System, Model…direct predicate · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K883614 | Cytoguard (R) | Survival Technology, Inc. | 1988 | — |
| −3 | K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic Agents | Quality System Consulting | 1997 | — |
| −2 | K980381 | Phaseal, Closed System Forhandling of Parenteral Drugs, Additional… | Carmel Pharma Ab. | 1998 | — |
| −1 | K071741 | Tevadaptor, Closed Drug Reconstitution and Transfer System | Migada Plant | 2007 | 1 |
| 0 (this device) | K132011 | Apoteca Dug Compounding Dosing Device,Apoteca I.V. Transfer Set | Aea Srl | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 1 |
| 2011 | 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110771 | BD Single Use, Hypodermic SyringeSummary page 1…Becton Dickinson Single Use Hypodermic Syringes Manufacturer: Becton, Dickinson and Company 510(k) Number K110771, K980g87 Trade Name: Two-Fer" Non-Coring Huber Point Needle Manufacturer: B… | 2011 |
| Kept off the family tree | K980987 | FDA’s K980987 is Becton Dickinson Syringe Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1998 |
| * | K832347 | Twofer NeedleSummary page 1…Name: Two-Fer" Non-Coring Huber Point Needle Manufacturer: BAXA CORP. Englewood CO 510(k) Number K832347 Trade Name: TEVADAPTOR T M Spike Port Adaptor Manufacturer: Teva Medical Lt… | 1983 |
| * | K071741 | Tevadaptor, Closed Drug Reconstitution and Transfer SystemSummary page 1…: TEVADAPTOR T M Spike Port Adaptor Manufacturer: Teva Medical Ltd. (Migada Plant) 510(k) Number K071741 Trade Name: TEVADAPTOR T M Connecting Set Manufacturer: Teva Medical Ltd. (… | 2007 |
| * | K980381 | Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration…Summary page 1…K071741 Trade Name: PhaSeaI Secondary Set Manufacturer: Carmel Pharma AB. 510(k) Number K980381 Trade Name: Exacta-Mix 2400 Compounding System Administration Set Manufacturer:… | 1998 |
| * | K002705 | Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400Summary page 1…Exacta-Mix 2400 Compounding System Administration Set Manufacturer: BAXA CORP. Englewood CO 510(k) Number: K002705 'mrt: 51C%'k)tm y- AFA OC40 CorUwwIdv MbV av.FModfe, *… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K002705Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400Baxa Corp. · 2001 · Direct predicate · ◆ in the 2001 ancestors bar of FIG. 16 Class I recalls
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 9.0 years on median.
- 5 of the 10 ancestors have a recall of any class; 1 has a Class I recall.
- 8 other devices also cite its predicate K110771.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The APOTECA Drug Compounding Dosing Device is indicated for use by pharmacists or other healthcare professionals for the preparation of chemotherapy drugs, for the transfer of drug from vials to IV bag for infusion. The drug transfer through the device can be performed manually or through an automatic pharmacy compounding system. The specific assembly configuration of the needle allows a robotic arm to manage the device and an automatic dosing device to…
Read the full statement (160 words)
The APOTECA Drug Compounding Dosing Device is indicated for use by pharmacists or other healthcare professionals for the preparation of chemotherapy drugs, for the transfer of drug from vials to IV bag for infusion. The drug transfer through the device can be performed manually or through an automatic pharmacy compounding system. The specific assembly configuration of the needle allows a robotic arm to manage the device and an automatic dosing device to transfer drug from a vial to a bag by applying pressure on the syringe plunger. The APOTECA Drug Compounding Dosing Device is intended for use with APOTECAchemo automatic compounding system or for manual drug compounding.
The APOTECA I.V. Transfer Set is a non-vented infusion set indicated to be used as a connecting part between the IV bag and an external IV line when the drug preparation is performed through an automatic pharmacy compounding system. The APOTECA I.V. Transfer Set is intended for use with APOTECAchemo automatic compounding system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132011 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132011: Apoteca Dug Compounding Dosing Device,Apoteca I.V. Transfer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132011
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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