510(k) · Cleared
ClearedPrecinorm (R) Protein
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · DAF Gamma Globulin, Fitc, Antigen, Antiserum, Control
Cleared on May 15, 1987 after a 60-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- May 15, 1987
- Review
- 60 days
- Class
- Class II
- Product code
- DAF
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK871027 Precinorm (R) ProteinBoehringer Mannheim Corp. · 1987
- Descendant · cites it directly · 7 of its ownK981401 Boehringer Mannheim Precinorm Precipath Protein ControlsBoehringer Mannheim Corp. · 1998
- Descendant · 2 generations on · 5 of its ownK040280 Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR…Roche Diagnostics Corp. · 2004
- Descendant · 3 generations on · 2 of its ownK041812 Modification to Roche Diagnostics Precinorm Proteins in Urine/CSF…Roche Diagnostics Corp. · 2004
- Descendant · 4 generations on · 1 of its ownK050026 Precinorm Proteins in Urine/CSF (Puc) and Precipath PucRoche Diagnostics · 2005
- Descendant · 2 generations on · 0 of its ownK133330 C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2…Roche Diagnostics · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K981401Boehringer Mannheim Precinorm Precipath Protein ControlsBoehringer Mannheim Corp. · 1998 · cites it directly7descendants
- K040280Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR ControlsRoche Diagnostics Corp. · 2004 · 2 generations on5descendants
- K041812Modification to Roche Diagnostics Precinorm Proteins in Urine/CSF (Puc) and Precipath…Roche Diagnostics Corp. · 2004 · 3 generations on2descendants
- K050026Precinorm Proteins in Urine/CSF (Puc) and Precipath PucRoche Diagnostics · 2005 · 4 generations on1descendant
- K133330C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm Protein &…Roche Diagnostics · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K871027 | Precinorm (R) Protein | Boehringer Mannheim Corp. | 1987 | — |
| +1 | K981401 | Boehringer Mannheim Precinorm Precipath Protein Controls | Boehringer Mannheim Corp. | 1998 | — |
| +2 | K040280 | Precinorm Proteins in Urine/CSF Precipath Proteins in Urine/CSR Controls | Roche Diagnostics Corp. | 2004 | — |
| +3 | K041812 | Modification to Roche Diagnostics Precinorm Proteins in Urine/CSF (Puc) and… | Roche Diagnostics Corp. | 2004 | — |
| +4 | K050026 | Precinorm Proteins in Urine/CSF (Puc) and Precipath Puc | Roche Diagnostics | 2005 | — |
| +2 | K133330 | C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm… | Roche Diagnostics | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DAF? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981401 | Boehringer Mannheim Precinorm Precipath Protein Controls | 1998 | 7 |
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?
- Of its descendants, K981401 (Boehringer Mannheim Corp., 1998) has gone furthest, with 7 descendants of its own.
How does its category compare?
All DAF devicesDAF Gamma Globulin, Fitc, Antigen, Antiserum, Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DAF
FDA has decided no DAF device since 2007.
Median 510(k) review, days · DAF
Too few DAF 510(k)s in any year since 2007 to give a median.
Recalls per year · DAF
No recall names DAF since 2007.
Adverse event reports per year · DAF
2in 2008
MAUDE reports naming product code DAF, 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 | 2 |
| 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 | — |
https://510kreport.com/device/K871027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K871027: Precinorm (R) Protein.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K871027
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026