510(k) · Cleared
ClearedRocket Mucus Sampler Syringe, Sterile, Rocket Mucus Sampler Syringe, Clinically Aspirator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A & A Medical, Inc. · HFC Aspirator, Endocervical
Cleared on Dec 22, 1997 after a 60-day review. The FDA summary names its predicate without a number.
- Decided
- Dec 22, 1997
- Review
- 60 days
- Class
- Class II
- Product code
- HFC
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 HFC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Aspirette Endocervical Aspirator from Unimar, Inc. Named without a submission number | |
| * | — | SelectMucus from Select Medical Systems, Inc Named without a submission number | |
| * | — | Cervical Mucous Aspiration Catheter from Cook Urological, Inc Named without a submission number |
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 HFC devicesHFC Aspirator, Endocervical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HFC
FDA has decided no HFC device since 2007.
Median 510(k) review, days · HFC
Too few HFC 510(k)s in any year since 2007 to give a median.
Recalls per year · HFC
No recall names HFC since 2007.
Adverse event reports per year · HFC
1in 2014
MAUDE reports naming product code HFC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 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 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Rocket Mucus Sampler is designed for optimum suction for the collection of cervical mucosal lining, post coital test (Huhner), external os or vaginal pool sampling.
The Rocket Mucous Sampler enables the Ob/Gyn physician to collect the specimen and send it to the laboratory to be examined histologically or cytologically
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/K974032 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974032: Rocket Mucus Sampler Syringe, Sterile, Rocket Mucus Sampler Syringe, Clinically Aspirator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974032
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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