Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Unipath , Ltd. — Predicate Candidate Screening
73 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
65 daysmedian FDA review time
158 days90th percentile
73clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061769 | E.P.T. CERTAINTY 1-STEP PREGNANCY TEST | Unipath , Ltd. | 2006-07-03 | 10 | 0 |
| K060128 | CLEARBLUE EASY DIGITAL PREGNANCY TEST | Unipath , Ltd. | 2006-05-25 | 127 | 0 |
| K051638 | INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC | Unipath , Ltd. | 2005-12-06 | 169 | 0 |
| K050930 | E.P.T. CERTAINTY PREGNANCY TEST | Unipath , Ltd. | 2005-05-12 | 28 | 0 |
| K042280 | FACT PLUS ONE-STEP PREGNANCY TEST KIT | Unipath , Ltd. | 2004-09-10 | 18 | 0 |
| K041404 | CLEARBLUE EASY EASY READ PREGNANCY TEST | Unipath , Ltd. | 2004-06-08 | 13 | 0 |
| K040329 | MODIFICATION TO E.P.T. PREGNANCY TEST | Unipath , Ltd. | 2004-03-08 | 26 | 0 |
| K040341 | CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST | Unipath , Ltd. | 2004-03-08 | 25 | 0 |
| K033658 | E.P.T. PREGNANCY TEST | Unipath , Ltd. | 2004-01-16 | 56 | 0 |
| K032939 | EPT CERTAINTY PREGNANCY TEST | Unipath , Ltd. | 2003-10-20 | 28 | 0 |
| K030659 | CLEARBLUE EASY DIGITAL PREGNANCY TEST | Unipath , Ltd. | 2003-05-02 | 60 | 0 |
| K023699 | CLEARBLUE EASY EARLY RESULT PREGNANCY TEST | Unipath , Ltd. | 2002-11-27 | 23 | 0 |
| K013874 | CLEARPLANE EASY OVULATION TEST | Unipath , Ltd. | 2002-02-19 | 90 | 0 |
| K013372 | CLEARBLUE EASY EARLY RESULT PREGNANCY TEST | Unipath , Ltd. | 2001-11-09 | 29 | 0 |
| K993333 | CLEARPLAN EASY II HOME PREGNANCY TEST | Unipath , Ltd. | 1999-12-16 | 73 | 0 |
| K993703 | CLEARVIEW EASY HCG PREGNANCY TEST | Unipath , Ltd. | 1999-12-02 | 30 | 0 |
| K990262 | CLEARPLAN EASY HOME PREGNANCY TEST | Unipath , Ltd. | 1999-04-07 | 70 | 0 |
| K990223 | MODIFICATION OF CLEARPLAN EASY FERTILITY MONITOR | Unipath , Ltd. | 1999-02-24 | 30 | 0 |
| K981946 | CLEARVIEW IM | Unipath , Ltd. | 1998-12-10 | 190 | 0 |
| K981207 | CLEARPLAN EASY FERTILITY MONITOR | Unipath , Ltd. | 1998-10-28 | 209 | 0 |
| K981271 | CLEARPLAN EASY OVULATION TEST | Unipath , Ltd. | 1998-06-25 | 79 | 0 |
| K964492 | CIPROFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Unipath , Ltd. | 1997-02-07 | 91 | 0 |
| K964495 | CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Unipath , Ltd. | 1997-02-07 | 91 | 0 |
| K964491 | NORFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Unipath , Ltd. | 1997-02-07 | 92 | 1 |
| K964490 | AZTREONAM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Unipath , Ltd. | 1997-02-07 | 91 | 0 |
| K964487 | IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Unipath , Ltd. | 1997-02-07 | 92 | 0 |
| K964489 | CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Unipath , Ltd. | 1997-02-07 | 91 | 0 |
| K964496 | CEFIXIME ANTIMICROBIAL SUSCEPTIBILTY TEST DISC | Unipath , Ltd. | 1997-02-06 | 90 | 0 |
| K964493 | OFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Unipath , Ltd. | 1997-02-06 | 90 | 0 |
| K964501 | SULBACTAM/AMPICILLIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Unipath , Ltd. | 1997-02-06 | 90 | 0 |
| K964512 | CEFTIZOXIME ANTIMICROBIAL SUSCEPTIBILITY TEST DISC | Unipath , Ltd. | 1997-02-06 | 90 | 0 |
| K962296 | STREPTOLEX-STAT | Unipath , Ltd. | 1996-12-16 | 187 | 0 |
| K955067 | CLEARVIEW C. DIFF A | Unipath , Ltd. | 1996-09-13 | 312 | 0 |
| K960316 | CLEARBLUE EASY | Unipath , Ltd. | 1996-04-29 | 97 | 0 |
| K940557 | STAPHYTECT-OD | Unipath , Ltd. | 1994-07-28 | 171 | 0 |
| K934923 | CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET | Unipath , Ltd. | 1993-12-29 | 77 | 0 |
| K934922 | CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET | Unipath , Ltd. | 1993-12-29 | 77 | 0 |
| K924673 | CLEARVIEW HCG | Unipath , Ltd. | 1993-05-11 | 237 | 0 |
| K913305 | CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER | Unipath , Ltd. | 1991-11-22 | 120 | 1 |
| K914240 | CLEARVIEW HCG SERUM/URINE PROFESS PREG TEST, MODIF | Unipath , Ltd. | 1991-10-25 | 51 | 0 |
| K905741 | CLEARVIEW HCG SERUM/URINE | Unipath , Ltd. | 1991-05-15 | 142 | 0 |
| K911566 | CLEARBLUE EASY | Unipath , Ltd. | 1991-05-06 | 27 | 0 |
| K910946 | CLEARVIEW HCG | Unipath , Ltd. | 1991-04-01 | 26 | 0 |
| K905742 | CLEARBLUE EASY | Unipath , Ltd. | 1991-02-13 | 51 | 0 |
| K903665 | CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY | Unipath , Ltd. | 1990-10-04 | 50 | 0 |
| K902892 | CELL-DYN CALIBRATOR | Unipath , Ltd. | 1990-09-10 | 70 | 1 |
| K902391 | CELL-DYN 3000 CONTROL | Unipath , Ltd. | 1990-08-22 | 84 | 0 |
| K895280 | CLEARVIEW CHLAMYDIA | Unipath , Ltd. | 1990-01-29 | 158 | 0 |
| K894579 | CLEARPLAN EASY | Unipath , Ltd. | 1989-10-12 | 80 | 0 |
| K893422 | CLEARVIEW STREP A | Unipath , Ltd. | 1989-06-23 | 52 | 0 |
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