510(k) · Cleared
ClearedSperm-Select Additional Indication
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmacia, Inc. · HDR Cap, Cervical
Cleared on Sep 28, 1987 after a 70-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Sep 28, 1987
- Review
- 70 days
- Class
- Class II
- Product code
- HDR
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK872849 Sperm-Select Additional IndicationPharmacia, Inc. · 1987
- Descendant · cites it directly · 4 of its ownK971809 IsolateIrvine Scientific Sales Co., Inc. · 1997
- Descendant · 2 generations on · 1 of its ownK991341 Isolate, Isolate Concentrate, Isolate Stock SolutionIrvine Scientific Sales Co., Inc. · 1999 · Recalled
- Descendant · cites it directly · 1 of its ownK980814 PurespermNidacon International AB · 1998
- Descendant · 3 generations on · 0 of its ownK023403 Spermgrad, Models 10022/10063Vitrolife Sweden AB · 2002
- Descendant · 2 generations on · 0 of its ownK984172 Modification of PurespermNidacon International AB · 1999
Most influential descendants
Showing 5 of 5 · See all- K971809IsolateIrvine Scientific Sales Co., Inc. · 1997 · cites it directly4descendants
- K991341Isolate, Isolate Concentrate, Isolate Stock SolutionIrvine Scientific Sales Co., Inc. · 1999 · 2 generations on1descendant
- K980814PurespermNidacon International AB · 1998 · cites it directly1descendant
- K023403Spermgrad, Models 10022/10063Vitrolife Sweden AB · 2002 · 3 generations on0descendants
- K984172Modification of PurespermNidacon International AB · 1999 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K872849 | Sperm-Select Additional Indication | Pharmacia, Inc. | 1987 | — |
| +1 | K971809 | Isolate | Irvine Scientific Sales Co., Inc. | 1997 | — |
| +2 | K991341 | Isolate, Isolate Concentrate, Isolate Stock Solution | Irvine Scientific Sales Co., Inc. | 1999 | 1 |
| +1 | K980814 | Puresperm | Nidacon International AB | 1998 | — |
| +3 | K023403 | Spermgrad, Models 10022/10063 | Vitrolife Sweden AB | 2002 | — |
| +2 | K984172 | Modification of Puresperm | Nidacon International AB | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 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 HDR? 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 HDR device
- #1 K242031 Béa Applicator (BAP-GB-01)score 9.4 · 2 generations · no Class I recall
- #2 Held for the reportin 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? (5)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K971809 (Irvine Scientific Sales Co., Inc., 1997) has gone furthest, with 4 descendants of its own.
How does its category compare?
All HDR devicesHDR Cap, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HDR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HDR
Too few HDR 510(k)s in any year since 2007 to give a median.
Recalls per year · HDR
No recall names HDR since 2007.
Adverse event reports per year · HDR
1in 2014
MAUDE reports naming product code HDR, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 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 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K872849 · printed Nov 4, 2026
Cite this page
510(k) Report. “K872849: Sperm-Select Additional Indication.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K872849
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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