Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
MQH — Predicate Candidate Screening
26 FDA 510(k) clearances under this product code; the 50 most recent screened below.
145 daysmedian FDA review time
262 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250838 | Denudation Pipettes | Guangzhou Pinzhi Medical Device Co., Ltd. | 2025-07-03 | 105 | 0 |
| K192146 | V-DENUPET | Vitromed GmbH | 2020-01-28 | 173 | 0 |
| K161275 | EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip | Research Instruments Limited | 2017-01-23 | 262 | 0 |
| K152581 | LifeGlobal Micro Tips | Life Global Group, LLC | 2016-04-11 | 214 | 0 |
| K151018 | Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular | Cook Incorporated | 2016-01-08 | 267 | 0 |
| K150748 | Flexipet Denuding Pipette, Flexipet Manipulation Pipette | Cook Incorporated | 2015-12-18 | 270 | 0 |
| K133257 | BIOPSY PIPETTES | Research Instruments , Ltd. | 2014-05-16 | 205 | 0 |
| K102480 | INJECTION PIPETTE; HOLDING PIPETTE; BIOPSY PIPETTE; DENUDING | Jieying Laboratory, Inc. | 2011-04-19 | 232 | 0 |
| K092554 | BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES | Sunlight Medical, Inc. | 2010-04-30 | 253 | 0 |
| K072600 | INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZON | Sunlight Medical, Inc. | 2008-05-19 | 248 | 0 |
| K041435 | THE STRIPPER PGD | Mid-Atlantic Diagnostics, Inc. | 2004-09-29 | 124 | 0 |
| K041562 | CRYOTIP | Irvine Scientific Sales Co., Inc. | 2004-08-09 | 60 | 0 |
| K033904 | PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES | Cook Urological, Inc. | 2004-01-16 | 30 | 0 |
| K033903 | MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MIC | Cook Urological, Inc. | 2004-01-16 | 30 | 0 |
| K024302 | PRECISION CAPILLARIES FOR MICROMANIPULATION | Brinkmann Instruments, Inc. | 2003-02-19 | 57 | 0 |
| K022643 | BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 | Swemed Lab International AB | 2002-11-05 | 89 | 0 |
| K012811 | BLASTOMERE BIOPSY MICROPIPET, POLAR BODY MICROPIPET, MODELS | Humagen Fertility Diagnostics, Inc. | 2002-02-11 | 173 | 0 |
| K001615 | HUNTER SCIENTIFIC INJECTION PIPETTES | Hunter Scientific Limited | 2000-08-18 | 85 | 0 |
| K993699 | THE STRIPPER | Mid-Atlantic Diagnostics, Inc. | 2000-05-16 | 196 | 0 |
| K991388 | ASSISTED HATCHING MICROPIPETTES, DENUDING PIPETTES, HOLDING | Pacific Andrology, Inc. | 1999-09-13 | 145 | 0 |
| K991261 | ICSI INJECTION MICROPIPETTE (SPIKED & NON-SPIKED), ICSI HOLD | Research Instruments , Ltd. | 1999-08-05 | 114 | 0 |
| K991700 | SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTI | Swemed Lab International AB | 1999-07-19 | 62 | 0 |
| K991104 | MICROTOOLS | Conception Technology, Inc. | 1999-07-19 | 109 | 0 |
| K990847 | INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATI | Humagen Fertility Diagnostics, Inc. | 1999-07-14 | 121 | 0 |
| K983713 | PRODIMED MICROINJECTION PIPETTES | Prodimed | 1999-06-08 | 230 | 0 |
| K983596 | INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPE | Cook Ob/Gyn | 1999-02-05 | 115 | 3 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda