510(k) · Cleared
ClearedThe Sensititre Aim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trek Diagnostic Systems · LIE Reagent/Device, Inoculum Calibration
Cleared on Jun 22, 2011 after a 210-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 22, 2011
- Review
- 210 days
- Class
- Class II
- Product code
- LIE
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
Planning a device in LIE? 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 LIE device
- #1 K221493 MicroScan Prompt Inoculation System-Dscore 5.1 · 1 generation · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All LIE devicesLIE Reagent/Device, Inoculum Calibration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LIE
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LIE
Too few LIE 510(k)s in any year since 2007 to give a median.
Recalls per year · LIE
No recall names LIE since 2007.
Adverse event reports per year · LIE
No MAUDE report names LIE since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Sensititre®D AIM' h is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® AIM' h is an instrument used to inoculate Sensititre® MIC or BP Susceptibility plates. The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae, other Streptococci…
Read the full statement (165 words)
The Sensititre®D AIM' h is intended for use with the Sensititre® MIC or BP Susceptibility Test System. The Sensititre® AIM' h is an instrument used to inoculate Sensititre® MIC or BP Susceptibility plates.
The Sensititre MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of gram positive and fastidious organisms comprising of Haemophilus influenzae, Streptococci pneumoniae, other Streptococci spp. and Candida spp.
NOTE: Please refer to the Sensititre ®D18-24 hour MIC or Breakpoint Susceptibility System package insert or operator's manual for additional instructions, limitations and references.
This 510(k) is for the addition of: "AIM"
The Sensititre AIMTM is a microprocessor controlled instrument that delivers inoculum in 50µl multiples to the Sensititre 96 well micro-titre plate. The user prepares the inoculum suspension in accordance with the package insert. A Sensititre disposable dosehead is affixed to the glass tube containing the final inoculum density which is placed into the AIM's pump assembly. The inoculum is then dispensed into the microtitre plates.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K103456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103456: The Sensititre Aim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103456
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026