Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
- 510(k)K123567Substantially equivalent (SESE) · 2013-09-10clearance family
Predicate lineage
K123567
Cited as predicate by: K182328
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-08-12 | NAI | No action indicated | Church & Dwight Manufacturing Co., Ltd. | 0 |
| 2024-07-18 | NAI | No action indicated | Church & Dwight Canada Corp. | 0 |
| 2023-08-08 | NAI | No action indicated | Church & Dwight Manufacturing Co., Ltd. | 0 |
| 2022-07-15 | NAI | No action indicated | Church & Dwight Manufacturing Co., Ltd. | 0 |
| 2020-08-14 | NAI | No action indicated | Church & Dwight Inc | 0 |
| 2020-08-14 | NAI | No action indicated | Church & Dwight Inc | 0 |
| 2017-10-31 | VAI | Voluntary action indicated | Church & Dwight Manufacturing Co., Ltd. | 1 |
| 2015-08-06 | NAI | No action indicated | Church & Dwight Inc | 0 |
| 2015-08-06 | NAI | No action indicated | Church & Dwight Inc | 0 |
| 2015-03-13 | VAI | Voluntary action indicated | Church & Dwight Manufacturing Co., Ltd. | 2 |
| 2012-08-24 | VAI | Voluntary action indicated | Church & Dwight Manufacturing Co., Ltd. | 2 |
| 2012-02-13 | VAI | Voluntary action indicated | Church & Dwight Inc | 5 |
| 2012-02-13 | VAI | Voluntary action indicated | Church & Dwight Inc | 5 |
| 2011-05-16 | WL | Warning Letter | Church & Dwight Inc | — |
| 2011-05-16 | WL | Warning Letter | Church & Dwight Inc | — |
| 2011-02-17 | NAI | No action indicated | Church & Dwight Co., Inc. | 0 |
| 2011-02-17 | OAI | Official action indicated | Church & Dwight Inc | 7 |
| 2011-02-17 | OAI | Official action indicated | Church & Dwight Inc | 7 |
| 2010-07-08 | VAI | Voluntary action indicated | Church & Dwight Manufacturing Co., Ltd. | 3 |
Similar devices
- INSTANT Aid By PUR-est Weihai Kangzhou Biotechnology Engineering Co., Ltd
- Instant-View HCG Midstream Cassette ALFA SCIENTIFIC DESIGNS, INC.
- Instant-View HCG Midstream Cassette, 2t ALFA SCIENTIFIC DESIGNS, INC.
- NATALIST PREGNANCY TEST MIDSTREAM 2 COUNT Equinox Biotech Co., Ltd.
- 6 days Ahead Pregnancy Test (3 HCG Midstreams) Equinox Biotech Co., Ltd.
- 7 Select Early Result Pregnancy Test 7-ELEVEN, INC.
- ACCU NEWS Ovulation Test + Pregnancy Test Combo CORETESTS, INC.
- ACCU NEWS Pregnancy Test Midstream CORETESTS, INC.
- ACESO Early Pregnancy Test ACESO LABORATORIES INC.
- ACESO Early Pregnancy Test ACESO LABORATORIES INC.
- ACESO Early Pregnancy Test ACESO LABORATORIES INC.
- ACESO Early Pregnancy Test ACESO LABORATORIES INC.
Select up to two to place side-by-side with this device.