Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Isle Media and Sterile Products, Inc. · Predicate Candidate Screening
93 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
38 days90th percentile
93clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K831671 | MODIFIED SOYBEAN CASEIN DIGEST BROTH | Isle Media and Sterile Products, Inc. | 1983-07-28 | 66 | 0 |
| K821218 | CAMPY-S AGAR | Isle Media and Sterile Products, Inc. | 1982-05-14 | 17 | 0 |
| K820863 | MEDIA FOR IN-VITRO DIAGNOSTIC USE | Isle Media and Sterile Products, Inc. | 1982-04-16 | 18 | 0 |
| K812795 | ANAEROBIC BLOOD AGAR | Isle Media and Sterile Products, Inc. | 1981-10-20 | 14 | 0 |
| K812796 | ANAEROBIC CNA BLOOD AGAR | Isle Media and Sterile Products, Inc. | 1981-10-20 | 14 | 0 |
| K812797 | SCHAEDLER AGARS | Isle Media and Sterile Products, Inc. | 1981-10-20 | 14 | 0 |
| K812798 | MOTILITY GI MEDIUM | Isle Media and Sterile Products, Inc. | 1981-10-20 | 14 | 0 |
| K800807 | CORN MEAL AGAR MEDIA | Isle Media and Sterile Products, Inc. | 1980-04-24 | 14 | 0 |
| K800818 | CHLAMYDOSPORE AGAR | Isle Media and Sterile Products, Inc. | 1980-04-24 | 13 | 0 |
| K800333 | MODIFIED THAYER-MARTIN X AGAR | Isle Media and Sterile Products, Inc. | 1980-03-03 | 18 | 0 |
| K800334 | MARTIN-LEWIS AGAR | Isle Media and Sterile Products, Inc. | 1980-03-03 | 18 | 0 |
| K800156 | STAPHYLOCOCCUS MED. 110 | Isle Media and Sterile Products, Inc. | 1980-02-13 | 20 | 0 |
| K800157 | BISMUTH SULFITE AGAR | Isle Media and Sterile Products, Inc. | 1980-02-13 | 20 | 0 |
| K800158 | AZIDE BLOOD AGAR BASE W/&WTHOT SHP. BLD | Isle Media and Sterile Products, Inc. | 1980-02-13 | 20 | 0 |
| K792423 | TODD HEWITT BROTH | Isle Media and Sterile Products, Inc. | 1980-01-09 | 43 | 0 |
| K792420 | SIM MEDIUM | Isle Media and Sterile Products, Inc. | 1979-12-31 | 34 | 0 |
| K792421 | DECARBOXYLASE BROTH BASE WITH OR WITH- | Isle Media and Sterile Products, Inc. | 1979-12-31 | 34 | 0 |
| K792422 | TETRATHIONATE BROTH BASE | Isle Media and Sterile Products, Inc. | 1979-12-31 | 34 | 0 |
| K792542 | VOGEL-JOHNSON AGAR | Isle Media and Sterile Products, Inc. | 1979-12-31 | 21 | 0 |
| K792593 | PHENYLETHANOL AGAR | Isle Media and Sterile Products, Inc. | 1979-12-31 | 14 | 0 |
| K792594 | TRYPTIC SOY AGAR W/LECITHIN & POLYSRBTE. | Isle Media and Sterile Products, Inc. | 1979-12-31 | 14 | 0 |
| K792595 | SF MEDIUM (SF BROTH, STREPTOCOCCUS | Isle Media and Sterile Products, Inc. | 1979-12-31 | 14 | 0 |
| K792596 | TRYPTIC SOY AGAR W/PHENYLETHANOL & | Isle Media and Sterile Products, Inc. | 1979-12-31 | 14 | 0 |
| K792424 | CHOCOLATE TELLURITE AGAR | Isle Media and Sterile Products, Inc. | 1979-12-27 | 30 | 0 |
| K792425 | DECARBOXYLASE MOELLER BASE WITH OR WITH- | Isle Media and Sterile Products, Inc. | 1979-12-27 | 30 | 0 |
| K792543 | TRYPTOSE BLOOD AGAR BASE & TRYPTOSE | Isle Media and Sterile Products, Inc. | 1979-12-27 | 17 | 0 |
| K792544 | LYSINE IRON AGAR | Isle Media and Sterile Products, Inc. | 1979-12-27 | 17 | 0 |
| K792286 | MR-VP MEDIUM | Isle Media and Sterile Products, Inc. | 1979-12-19 | 36 | 0 |
| K792287 | KF STREPTOCOCCUS AGAR | Isle Media and Sterile Products, Inc. | 1979-12-19 | 36 | 0 |
| K792288 | TRYPTONE BROTH (TRYPTOPHANE BROTH) | Isle Media and Sterile Products, Inc. | 1979-12-19 | 36 | 0 |
| K791939 | PHENOL RED AGAR | Isle Media and Sterile Products, Inc. | 1979-10-30 | 29 | 0 |
| K791940 | UREA AGAR | Isle Media and Sterile Products, Inc. | 1979-10-30 | 29 | 0 |
| K791941 | PHENOL RED BROTH | Isle Media and Sterile Products, Inc. | 1979-10-30 | 29 | 0 |
| K791942 | BILE ESCULIN AZIDE AGAR | Isle Media and Sterile Products, Inc. | 1979-10-30 | 29 | 0 |
| K791943 | NUTRIENT AGAR | Isle Media and Sterile Products, Inc. | 1979-10-30 | 29 | 0 |
| K791944 | NITRATE AGAR | Isle Media and Sterile Products, Inc. | 1979-10-30 | 29 | 0 |
| K791945 | NITRATE BROTH | Isle Media and Sterile Products, Inc. | 1979-10-30 | 29 | 0 |
| K791946 | OF BASAL MEDIUM | Isle Media and Sterile Products, Inc. | 1979-10-30 | 29 | 0 |
| K791815 | MUELLER HINTON CHOCOLATE | Isle Media and Sterile Products, Inc. | 1979-10-04 | 20 | 0 |
| K791670 | SABOURAUD AGAR MODIFIED | Isle Media and Sterile Products, Inc. | 1979-10-01 | 34 | 0 |
| K791671 | DNASE TEST AGAR | Isle Media and Sterile Products, Inc. | 1979-10-01 | 34 | 0 |
| K791813 | DNASE TEST AGAR W/METHYL GREEN | Isle Media and Sterile Products, Inc. | 1979-10-01 | 17 | 0 |
| K791814 | BILE ESCULIN AGAR | Isle Media and Sterile Products, Inc. | 1979-10-01 | 17 | 0 |
| K791816 | DC AGAR (DESOXYCHOLATE CITRATE AGAR) | Isle Media and Sterile Products, Inc. | 1979-10-01 | 17 | 0 |
| K791817 | MIO MEDIUM (MOTILITY INDOLE ORNITHINE) | Isle Media and Sterile Products, Inc. | 1979-10-01 | 17 | 0 |
| K791818 | MUELLER HINTON MEDIUM W/SHEEP BLOOD | Isle Media and Sterile Products, Inc. | 1979-10-01 | 17 | 0 |
| K791626 | MYCOBIOTIC AGAR | Isle Media and Sterile Products, Inc. | 1979-09-27 | 37 | 0 |
| K791627 | MANNITOL SALT AGAR | Isle Media and Sterile Products, Inc. | 1979-09-27 | 37 | 0 |
| K791628 | BRAIN HEART INFUSION AGAR 5% SHEEP BLOOD | Isle Media and Sterile Products, Inc. | 1979-09-27 | 37 | 0 |
| K791629 | BRAIN HEART CC AGAR | Isle Media and Sterile Products, Inc. | 1979-09-27 | 37 | 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