510(k) · Cleared
ClearedAcon Spectrum Urine/Serum Pregnancy Test Device
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 Aug 16, 2004 as substantially equivalent to K993065 (ACON Laboratories, Inc., 1999) after a 28-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.
- Decided
- Aug 16, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- JHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993065 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK993065 Acon Combo PregnancyACON Laboratories, Inc. · 1999 · Recalled
- This deviceK041946 Acon Spectrum Urine/Serum Pregnancy Test DeviceACON Laboratories, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK071030 Bionexia HCG Pregnancy Serum/Urine Cassette and Dipstick Tests…Applied Dna Technologies, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K071030Bionexia HCG Pregnancy Serum/Urine Cassette and Dipstick Tests, Models 08-HCGC and 02-HCGCApplied Dna Technologies, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993065 | Acon Combo Pregnancy | ACON Laboratories, Inc. | 1999 | 1 |
| 0 (this device) | K041946 | Acon Spectrum Urine/Serum Pregnancy Test Device | ACON Laboratories, Inc. | 2004 | — |
| +1 | K071030 | Bionexia HCG Pregnancy Serum/Urine Cassette and Dipstick Tests, Models 08-HCGC… | Applied Dna Technologies, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K993065 | Acon Combo PregnancySummary page 2…cate that the ACON SPECTRUM Urine/Serum Pregnancy Test Device is safe, effective and substantially equivalent to the ACON hCG Urine/Serum One Step Pregnancy Test Device (K993065) legally sold on the U. S. market. 34 DEPARTMENT OF HEALTH… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071030 | Bionexia HCG Pregnancy Serum/Urine Cassette and Dipstick Tests, Models 08-HCGC and 02-HCGC | 2007 | 0 |
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?
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?
The ACON SPECTRUM Urine/Serum Pregnancy Test Device is
intended for the qualitative identification the elevated level of human
Chorionic Gonadotropin (hCG) in urine and serum to aid in the
determination of pregnancy. It is for healthcare professionals only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041946 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041946: Acon Spectrum Urine/Serum Pregnancy Test Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041946
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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