510(k) · Cleared
Recalled · 2011Cryopette
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mid-Atlantic Diagnostics, Inc. · MQK Labware, Assisted Reproduction
Cleared on Dec 6, 2010 as substantially equivalent to K041562 (Irvine Scientific Sales Co., Inc., 2004) after a 279-day review. Its family tree reaches back 1 generation to 2004. It has been recalled once.
- Decided
- Dec 6, 2010
- Review
- 279 days
- Class
- Class II
- Product code
- MQK
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041562 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK041562 CryotipIrvine Scientific Sales Co., Inc. · 2004
- This deviceK100596 CryopetteMid-Atlantic Diagnostics, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041562 | Cryotip | Irvine Scientific Sales Co., Inc. | 2004 | — |
| 0 (this device) | K100596 | Cryopette | Mid-Atlantic Diagnostics, Inc. | 2010 | — |
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
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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 |
|---|---|---|---|
| * | K041562 | CryotipSummary page 1…tion container Classification Name: Assisted Reproduction Labware (21 CFR 884.6160) Product Code: MQK Predicate Device: Irvine Scientific CryoTip (K041562) Description: The Cryopette consists of a cryostraw manufactured from polycarbonate-Lexan OQ-3820. This straw has a displacemen… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 28, 2011 | Not classified | Z-1094-2012 | Device Design | Cryopettes were rupturing during the warming process following vitrification. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K041562.
How does its category compare?
All MQK devicesMQK Labware, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MQK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQK
259in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQK
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQK
1in 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?
The Cryopette is a cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100596 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100596: Cryopette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100596
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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