510(k) · Cleared
ClearedAir Bubble Based Infuser (ABBI)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CooperSurgical, Inc. · LKF Cannula, Manipulator/Injector, Uterine
Cleared on Feb 26, 2015 as substantially equivalent to K110288 (Femasys, Inc., 2011) after a 90-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Feb 26, 2015
- Review
- 90 days
- Class
- Class II
- Product code
- LKF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K881680 (1988). No later device cites it as a predicate yet.
- Root · 3 generations backK881680 Ackrad H/S Procedure TrayAckrad Laboratories · 1988
- 2 generations backK020954 H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere…Ackrad Laboratories · 2002
- 1 generation backK110288 Femvue Saline-Air DeviceFemasys, Inc. · 2011
- This deviceK143415 Air Bubble Based Infuser (ABBI)CooperSurgical, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K881680 | Ackrad H/S Procedure Tray | Ackrad Laboratories | 1988 | — |
| −2 | K020954 | H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere Procedure… | Ackrad Laboratories | 2002 | — |
| −1 | K110288 | Femvue Saline-Air Device | Femasys, Inc. | 2011 | — |
| 0 (this device) | K143415 | Air Bubble Based Infuser (ABBI) | CooperSurgical, Inc. | 2015 | — |
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.
Planning a device in LKF? 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 LKF device
- #1 K241693 FemChec Controlled Saline-Air Device (FCD-250)score 11.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K110288 | Femvue Saline-Air DeviceSummary page 4…Manipulator/Injector, Unclassified LKF Uterine Predicate Information: FemVue Saline-Air Device (Femasys, Inc.) – K110288 Device Description: The Air Bubble-Based Infuser (ABBITM) is a dual-barrel syringe that can be connected to an intrauterine inf… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K110288.
How does its category compare?
All LKF devicesLKF Cannula, Manipulator/Injector, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · LKF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LKF
136in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LKF
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKF
95in 2025
MAUDE reports naming product code LKF, 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 | 3 | 141 | 0 | 36 |
| 2008 | 0 | — | 2 | 59 |
| 2009 | 2 | — | 0 | 53 |
| 2010 | 6 | 178 | 0 | 46 |
| 2011 | 3 | 187 | 0 | 98 |
| 2012 | 0 | — | 2 | 104 |
| 2013 | 3 | 266 | 0 | 53 |
| 2014 | 3 | 169 | 0 | 45 |
| 2015 | 5 | 140 | 0 | 53 |
| 2016 | 1 | — | 0 | 62 |
| 2017 | 1 | — | 0 | 64 |
| 2018 | 4 | 267 | 0 | 23 |
| 2019 | 1 | — | 0 | 76 |
| 2020 | 0 | — | 0 | 119 |
| 2021 | 0 | — | 0 | 189 |
| 2022 | 4 | 79 | 3 | 100 |
| 2023 | 0 | — | 0 | 88 |
| 2024 | 3 | 136 | 0 | 125 |
| 2025 | 2 | — | 0 | 95 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ABBI (Air Bubble Based Infuser) is indicated for the following:
- Instillation of a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (SonoHSG).
- Instillation of saline as a continuous stream of contrast media into the uterus to be used in conjunction with an intrauterine catheter for performance of saline infusion sonography (SIS).
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/K143415 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143415: Air Bubble Based Infuser (ABBI).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143415
Report an extraction error
Are you the manufacturer?
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