510(k) · Cleared
ClearedAmniostat-FLM-PG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Irvine Scientific Sales Co., Inc. · JHG Chromatographic Separation, Lecithin/Sphingomyelin Ratio
Cleared on Oct 18, 2006 as substantially equivalent to K822150 (Hana Biologics, Inc., 1982) after a 135-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- Oct 18, 2006
- Review
- 135 days
- Class
- Class II
- Product code
- JHG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K822150 (1982). No later device cites it as a predicate yet.
- Root · 1 generation backK822150 Amnistat-FLMHana Biologics, Inc. · 1982
- This deviceK061549 Amniostat-FLM-PGIrvine Scientific Sales Co., Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K822150 | Amnistat-FLM | Hana Biologics, Inc. | 1982 | — |
| 0 (this device) | K061549 | Amniostat-FLM-PG | Irvine Scientific Sales Co., Inc. | 2006 | — |
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 JHG? 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? (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 |
|---|---|---|---|
| * | K822150 | Amnistat-FLMSummary page 1…ication Name: Lecithin/Sphingomyelin Ratio in Amniotic Fluid (21 CFR, 862.1455) Predicate Device: AmnioStat-FLM (K822150), Lecithin/Sphingomyelin ratio in amniotic fluid test system (21 CFR 862.1455) Description: The AmnioStat-FLM-P… | 1982 |
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.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All JHG devicesJHG Chromatographic Separation, Lecithin/Sphingomyelin Ratio: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHG
FDA has decided no JHG device since 2007.
Median 510(k) review, days · JHG
Too few JHG 510(k)s in any year since 2007 to give a median.
Recalls per year · JHG
No recall names JHG since 2007.
Adverse event reports per year · JHG
No MAUDE report names JHG 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 | 0 | — | 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 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AmnioStat-FLM-PG Kit is intended to be used for the immunological detection of phosphatidylglycerol (PG) in amniotic fluid to determine fetal lung maturity of the fetus collected from transabdominal or vaginal pool samples.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061549: Amniostat-FLM-PG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061549
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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