Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LIO — Predicate Candidate Screening
63 FDA 510(k) clearances under this product code; the 50 most recent screened below.
77 daysmedian FDA review time
176 days90th percentile
63clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222613 | ARX Liquid Amies Collection & Transport System | Arx Sciences, Inc. | 2024-03-27 | 575 | 0 |
| K131630 | PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEM | Puritan Medical Products, LLC | 2013-10-21 | 139 | 0 |
| K120846 | TRANSPORT CULTURE MEDIUM DEVICE | Puritan Medical Products, LLC | 2012-06-08 | 80 | 0 |
| K103805 | MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQU | Medical Wire & Equipment Company (Bath), Ltd. | 2011-01-25 | 28 | 0 |
| K082472 | VIROCULT, MODEL MW950 | Medical Wire & Equipment Company (Bath), Ltd. | 2008-12-30 | 124 | 0 |
| K070062 | COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES | Diesse Diagnostica Senese S.P.A. | 2007-07-30 | 206 | 0 |
| K013711 | BACTI-SWAB DRY | Remel Co. | 2001-11-26 | 19 | 0 |
| K003761 | NAT - NUCLEIC ACID TRANSPORT | Medical Packaging Corp. | 2001-05-31 | 176 | 0 |
| K983119 | ENTERO-TEST HP, MODEL #102-01 | Hdc Corp. | 1999-03-15 | 188 | 0 |
| K981391 | PAR-ONE | Remel, Inc. | 1998-07-14 | 88 | 0 |
| K964144 | PARACON PLUS FORMALIN - PCP-F, PARACON PLUS SAF - PCP-SAF AN | Para Scientific Co. | 1996-11-27 | 41 | 0 |
| K963986 | STP SYSTEM PVA WITH ZINC | Sage Products, Inc. | 1996-11-08 | 35 | 0 |
| K964026 | STP SYSTEM - SAF | Sage Products, Inc. | 1996-11-07 | 31 | 0 |
| K964027 | STP SYSTEM-PVA WITH MERCURY | Sage Products, Inc. | 1996-11-01 | 25 | 0 |
| K960997 | STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM | Starplex Scientific, Inc. | 1996-04-03 | 22 | 0 |
| K953929 | MID-STREAM COLLECTION SET-STERILE | Trinity Laboratories, Inc. | 1995-11-16 | 87 | 0 |
| K950096 | PINWORM EGG COLLECTOR | Evergreen Industries, Inc. | 1995-04-05 | 85 | 0 |
| K931383 | ZINC PVA | Remel Co. | 1993-06-15 | 89 | 0 |
| K931770 | PARA-PAK PLUS | Meridian Diagnostics, Inc. | 1993-06-15 | 67 | 0 |
| K930313 | APEX SPECIMEN BAG | Apex Medical Technologies, Inc. | 1993-03-18 | 55 | 0 |
| K924053 | CYTOQUANT COMBINED TRANSPORT MEDIA | Proteins Intl., Inc. | 1993-01-15 | 156 | 0 |
| K924331 | TRANSYSTEM LIQUID STUART MEDIUM | Pro-Lab Diagnostics | 1992-12-24 | 119 | 0 |
| K924330 | TRANSYSTEM AMIES WITH CHARCOAL | Pro-Lab Diagnostics | 1992-12-24 | 119 | 0 |
| K924328 | TRANSYSTEM LIQUID AMIES MEDIUM | Pro-Lab Diagnostics | 1992-12-24 | 119 | 0 |
| K924329 | TRANSYSTEM AMIES W/O CHARCOAL | Pro-Lab Diagnostics | 1992-12-24 | 119 | 0 |
| K920536 | AFFIRM VP SAMPLE COLLECTION SET | Microprobe Corp. | 1992-07-30 | 176 | 0 |
| K920761 | URINE CULTUR STABILIZATION TRANSPORT TUBE | Bio Medicus, Inc. | 1992-06-19 | 121 | 0 |
| K915454 | CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT | Medical Packaging Corp. | 1992-04-08 | 125 | 0 |
| K912832 | BACTI-SWAB(TM) NPG | Remel Co. | 1991-08-22 | 57 | 0 |
| K912831 | BACTI-SWAB(TM) II | Remel Co. | 1991-07-30 | 34 | 0 |
| K903638 | GASTRO-INTESTINAL ACCU-CULSHURE TM | Medical Laboratory Automation Systems, Inc. | 1991-01-18 | 158 | 0 |
| K905120 | SAF FIXATIVE | Gibson Laboratories, Inc. | 1990-12-17 | 33 | 0 |
| K903406 | VIRAL ACCU-CULSHURE TM | Medical Laboratory Automation Systems, Inc. | 1990-10-16 | 77 | 0 |
| K903405 | CHLAMYDIA ACCU-CULSHURE TM | Medical Laboratory Automation Systems, Inc. | 1990-10-16 | 77 | 0 |
| K902467 | FLORA-STAT URINE TRANSPORT SYSTEM | Wadley Biosciences Corp. | 1990-08-22 | 79 | 0 |
| K896794 | SPECIMEN CONTAINER | Westmark, Sterile Packing Systems, Inc. (Sps) | 1990-03-01 | 90 | 0 |
| K900225 | ROMCHECK SPECIMEN COLLECTION KIT | Adeza Biomedical | 1990-02-02 | 16 | 2 |
| K893905 | PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1) | Diagnostic Products Corp. | 1989-08-03 | 65 | 0 |
| K890134 | FTK FECAL TRANSPORT KIT | Evergreen Scientific, Inc. | 1989-04-21 | 98 | 0 |
| K884342 | NOVAPATH SPECIMEN COLLECTION KIT | Bio-Rad | 1988-11-03 | 20 | 0 |
| K882485 | DIVERSI-KIT | Intl. Cancer Screening Laboratories, Inc. | 1988-07-18 | 32 | 0 |
| K873565 | SNAP(R) ROTAVIRUS DIAGNOSTIC KIT | Molecular Biosystems, Inc. | 1988-05-13 | 254 | 0 |
| K881125 | PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-03-23 | 7 | 0 |
| K874456 | CHLAMYDIA STAT DIRECT SMEAR COLLECTION KIT | Tm & M C/O Burditt,Bowles,Radzius & Ruberry, Ltd. | 1987-11-24 | 27 | 0 |
| K872751 | FLUORTRAN - C(TM) | Para Scientific Co. | 1987-07-23 | 10 | 0 |
| K871860 | NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT | Bio-Rad | 1987-05-29 | 16 | 0 |
| K870963 | MODIFIED PATHFINDER SPECIMEN COLLECTION KIT | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-04-08 | 29 | 0 |
| K870231 | KULTSURE | Ncs Diagnostics, Inc. | 1987-02-04 | 14 | 0 |
| K864727 | CULT-UR | R.P. Laboratories, Inc. | 1987-01-05 | 34 | 0 |
| K862607 | IMAGEN(TM) CHLAMYDIA SPECIMEN COLLECTION KIT | Boots-Celltech Diagnostics, Inc. | 1986-08-04 | 27 | 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