510(k) · Cleared
Recalled · Class II · 2026Acon Combo Pregnancy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Oct 8, 1999 after a 25-day review. The FDA summary names no predicate by number. 4 later devices descend from it. It has been recalled once.
- Decided
- Oct 8, 1999
- Review
- 25 days
- Class
- Class II
- Product code
- JHI
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK993065 Acon Combo PregnancyACON Laboratories, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK041946 Acon Spectrum Urine/Serum Pregnancy Test DeviceACON Laboratories, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK071030 Bionexia HCG Pregnancy Serum/Urine Cassette and Dipstick Tests…Applied Dna Technologies, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK050955 Lifesign Dxpress, Model LSR2000Princeton BioMeditech Corp. · 2006
- Descendant · cites it directly · 0 of its ownK051841 WH Accu Test One-Step Urine/Serum Combo Pregnancy TestW.H.P.M., Inc. · 2005
Most influential descendants
Showing 4 of 4 · See all- K041946Acon Spectrum Urine/Serum Pregnancy Test DeviceACON Laboratories, Inc. · 2004 · cites it directly1descendant
- K071030Bionexia HCG Pregnancy Serum/Urine Cassette and Dipstick Tests, Models 08-HCGC and 02-HCGCApplied Dna Technologies, Inc. · 2007 · 2 generations on0descendants
- K050955Lifesign Dxpress, Model LSR2000Princeton BioMeditech Corp. · 2006 · cites it directly0descendants
- K051841WH Accu Test One-Step Urine/Serum Combo Pregnancy TestW.H.P.M., Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993065 | Acon Combo Pregnancy | ACON Laboratories, Inc. | 1999 | — |
| +1 | K041946 | Acon Spectrum Urine/Serum Pregnancy Test Device | ACON Laboratories, Inc. | 2004 | — |
| +2 | K071030 | Bionexia HCG Pregnancy Serum/Urine Cassette and Dipstick Tests, Models 08-HCGC… | Applied Dna Technologies, Inc. | 2007 | — |
| +1 | K050955 | Lifesign Dxpress, Model LSR2000 | Princeton BioMeditech Corp. | 2006 | — |
| +1 | K051841 | WH Accu Test One-Step Urine/Serum Combo Pregnancy Test | W.H.P.M., Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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.
Planning a device in JHI? 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 JHI device
- #1 K262299 Instant-View® hCG Combo II Cassette Testscore 12.7 · 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?
The FDA summary names no predicate by number.
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 20, 2026 | Class II | Z-3272-2026 | Device Design | hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K041946 (ACON Laboratories, Inc., 2004) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JHI devicesJHI Visual, Pregnancy Hcg, Prescription Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JHI
101in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JHI
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHI
265in 2025
MAUDE reports naming product code JHI, 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 | 4 | 101 | 6 | 245 |
| 2008 | 0 | — | 8 | 29 |
| 2009 | 0 | — | 1 | 106 |
| 2010 | 1 | — | 2 | 143 |
| 2011 | 0 | — | 1 | 138 |
| 2012 | 2 | — | 0 | 219 |
| 2013 | 2 | — | 0 | 185 |
| 2014 | 2 | — | 0 | 112 |
| 2015 | 0 | — | 0 | 134 |
| 2016 | 1 | — | 0 | 143 |
| 2017 | 1 | — | 0 | 113 |
| 2018 | 1 | — | 0 | 132 |
| 2019 | 0 | — | 0 | 571 |
| 2020 | 0 | — | 0 | 114 |
| 2021 | 0 | — | 0 | 158 |
| 2022 | 1 | — | 0 | 126 |
| 2023 | 0 | — | 6 | 147 |
| 2024 | 1 | — | 1 | 256 |
| 2025 | 0 | — | 0 | 265 |
| 2026 | 1 | — | 4 | — |
What is it indicated for?
Acon™ Combo Pregnancy is intended for the rapid qualitative identification of hCG (human Chorionic Gonadotropin) in serum or urine to aid in the early determination of pregnancy. This test is for professional use.
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/K993065 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993065: Acon Combo Pregnancy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993065
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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