510(k) · Cleared

Cleared

Picsi Sperm Selection Device

K052457510(k) TraditionalCleared Apr 13, 2006218-day reviewClass II21 CFR 884.6160

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biocoat, Inc. · MQK Labware, Assisted Reproduction

Cleared on Apr 13, 2006 as substantially equivalent to K011607 (Nidacon International AB, 2001) and 1 other predicate after a 218-day review. Its family tree reaches back 2 generations to 1999.

Decided: Apr 13, 2006
Review: 218 days
Class: Class II
Product code: MQK
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K991343 (1999). 5 ancestors in all, the oldest K991253 (1999). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK991343 PVP (Polyvinylpyrrolidone)Irvine Scientific Sales Co., Inc. · 1999
1 generation backK011607 SpermcatchNidacon International AB · 2001
This deviceK052457 Picsi Sperm Selection DeviceBiocoat, Inc. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K991343	PVP (Polyvinylpyrrolidone)	Irvine Scientific Sales Co., Inc.	1999	—
−1	K011607	Spermcatch	Nidacon International AB	2001	—
0 (this device)	K052457	Picsi Sperm Selection Device	Biocoat, Inc.	2006	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2000	2	0

FIG. 1 — Lineage of K052457, 1999–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 MQK? 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 MQK device

#1 K241626 SperSort™ Sperm Sorting Chip (IPG02)score 10.1 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K011607	Spermcatch Summary page 1 …Assisted Reproduction Labware, CFR 884.6160, Class II, Procode 85 MQK PICSI is substantially equivalent to Sperm CatchTM Assisted Reproduction Media, (510(k) K011607, decision date: 8/10/2001) and to FALCON® IVF Round Dish, (510(k) K991253, decision date 5/5/1999). Description: The PICSITM Spe…	Nidacon International AB	2001	—
*	K991253	Falcon Ivf Round Dish Summary page 1 …85 MQK PICSI is substantially equivalent to Sperm CatchTM Assisted Reproduction Media, (510(k) K011607, decision date: 8/10/2001) and to FALCON® IVF Round Dish, (510(k) K991253, decision date 5/5/1999). Description: The PICSITM Sperm Selection Device is a sterile, plastic culture dish with three microdot…	Becton Dickinson Labware	1999	—

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?

The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
None of the 5 ancestors has a recall.

How does its category compare?

All MQK devices

MQK Labware, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQK

3in 2025

2007high 6 (2014) · low 0 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQK

259in 2025

2007high 454 (2012) · low 154 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQK

1in 2011

2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MQK

1in 2025

2007high 1 (2025) · low 0 (2007)2025

MAUDE reports naming product code MQK, 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	1	—	1	0
2008	2	—	0	0
2009	2	—	0	0
2010	2	—	0	0
2011	1	—	1	0
2012	3	454	0	0
2013	1	—	0	0
2014	6	270	0	0
2015	2	—	0	0
2016	2	—	0	0
2017	2	—	0	0
2018	4	154	0	0
2019	1	—	0	0
2020	2	—	0	0
2021	1	—	0	0
2022	2	—	0	0
2023	0	—	0	0
2024	4	163	0	0
2025	3	259	0	1
2026	1	—	0	—

What is it indicated for?

In the treatment of infertile couples by ICSI, PICSI is indicated for the selection of mature sperm for injection.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052457 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052457: Picsi Sperm Selection Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052457

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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