510(k) · Cleared
ClearedS dispensing line
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Dec 17, 2020 as substantially equivalent to K022523 (Baxa Corp., 2002) and 1 other predicate after a 444-day review. Its family tree reaches back 2 generations to 2001. 1 of the 3 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 17, 2020
- Review
- 444 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002705 (2001). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK002705 Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400Baxa Corp. · 2001 · Recalled (Class I)
- 1 generation backK022523 Rapid-Fill Tubeset, Model 90005Baxa Corp. · 2002
- This deviceK192770 S dispensing lineAea Srl · 2020
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
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? (2)
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 |
|---|---|---|---|
| * | K022523 | Rapid-Fill Tubeset, Model 90005Summary page 4…Rapid-Fill™ Tubeset Administration Set 510(k) number: K022523 K002705 IV DEVICE DESCRIPTION S dispensing line is a device for the transfer of liquids, with the p… | 2002 |
| * | K002705 | Exacta-Mix 2400 Compounding System, Model Exacta-Mix 2400Summary page 4…l™ Tubeset Administration Set 510(k) number: K022523 K002705 IV DEVICE DESCRIPTION S dispensing line is a device for the transfer of liquids, with the purpose of preparation of injectable… | 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 · ◆ on the line of descent in FIG. 16 Class I recalls
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 18.3 years on median.
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 S Dispensing Line is intended for transfer of liquid drug from bag to syringes through the APOTECAsyringe automated system. The device is used inside an automatic system APOTECAsyringe that tightens the tube with the syringe, while the connection with the bag is done manually. The transfer of liquid takes place by depression through the mechanical action on the piston of the syringe of a manipulator equipped with a gripping device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192770 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192770: S dispensing line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192770
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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