Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Otisville Biotech, Inc. · Predicate Candidate Screening
98 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
21 daysmedian FDA review time
67 days90th percentile
98clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K862396 | BIOTIS DECARBOXYLASE MEDIA, ARGININE | Otisville Biotech, Inc. | 1986-07-03 | 9 | 0 |
| K862390 | BIOTIS BORDET GENGOU AGAR | Otisville Biotech, Inc. | 1986-07-03 | 9 | 0 |
| K862389 | BIOTIS ACETAMIDE AGAR | Otisville Biotech, Inc. | 1986-07-03 | 9 | 0 |
| K862399 | BIOTIS SXT AGAR | Otisville Biotech, Inc. | 1986-07-03 | 9 | 0 |
| K862395 | BIOTIS DECARBOXYLASE MEDIA, BASE | Otisville Biotech, Inc. | 1986-07-03 | 9 | 0 |
| K862398 | BIOTIS DECARBOXYLASE MEDIA, ORNITHINE | Otisville Biotech, Inc. | 1986-07-03 | 9 | 0 |
| K862397 | BIOTIS DECARBOXYLASE MEDIA, LYSINE | Otisville Biotech, Inc. | 1986-07-03 | 9 | 0 |
| K862400 | BIOTIS KV LAKED BLOOD AGAR | Otisville Biotech, Inc. | 1986-07-03 | 9 | 0 |
| K862393 | BIOTIS LITMUS MILK | Otisville Biotech, Inc. | 1986-07-03 | 9 | 0 |
| K862394 | BIOTIS MITIS SALIVARIUS | Otisville Biotech, Inc. | 1986-07-03 | 9 | 0 |
| K862388 | BIOTIS TCBS AGAR | Otisville Biotech, Inc. | 1986-07-03 | 9 | 0 |
| K862387 | BIOTIS HAEMOPHILUS IDENTIFICATION QUAD | Otisville Biotech, Inc. | 1986-07-03 | 9 | 0 |
| K862391 | BIOTIS DESOXYCHOLATE AGAR | Otisville Biotech, Inc. | 1986-07-03 | 9 | 0 |
| K862392 | BIOTIS MOTILITY TEST MEDIUM | Otisville Biotech, Inc. | 1986-07-03 | 9 | 0 |
| K860395 | BIOTIS HAEMPHILLUS ISOLATION AGAR | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860408 | BIOTIS NUTRIENT AGAR | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860416 | BIOTIS REGAN-LOWE | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860399 | BIOTIS TODD HEWITT BROTH | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860384 | BIOTIS MODIFIED THAYER MARTIN | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860386 | BIOTIS SF BROTH | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860404 | BIOTIS MIDDLEBROOK 7H10 AGAR SLANT | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860397 | BIOTIS TSA | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860401 | BIOTIS TRYPTIC SOY AGAR SLANTS | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860413 | BIOTIS TSI | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860406 | BIOTIS MIDDLEBROOK 7H9 BROTH | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860405 | BIOTIS TSB WITH 6.5% NACL | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860402 | BIOTIS BISMUTH SULFITE AGAR | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860414 | BIOTIS ORNITHINE INDOLE MOTILITY MEDIA | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860390 | BIOTIS SABHI WITH CHLORAMPHENICAL AND GENTAMYCIN | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860394 | BIOTIS CETRIMIDE AGAR | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860410 | BIOTIS COOKED MEAT | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860391 | BIOTIS MIDDLEBROOK 7H11 BROTH & AGAR SLANT | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860411 | BIOTIS BHI AGAR | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860388 | BIOTIS KF STREPTOCOCCUS AGAR | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860396 | BIOTIS NUTRIENT GELATIN | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860412 | BIOTIS SIM MEDIUM | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860415 | BIOTIS SIMMON CITRATE AGAR | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860385 | BIOTIS MAC-MUG | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860407 | BIOTIS ANAEROBIC CNA | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860383 | BIOTIS CLOSTRIDIUM DIFFICILE AGAR | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860398 | BIOTIS POTATO DEXTROSE AGAR | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860403 | BIOTIS TSA WITH 5% RABBIT BLOOD | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K860409 | BIOTIS COLUMBIA SHEEP BLOOD AGAR | Otisville Biotech, Inc. | 1986-02-24 | 21 | 0 |
| K850565 | BIOTIS CHOCOLATE TELLURITE | Otisville Biotech, Inc. | 1985-03-13 | 29 | 0 |
| K844195 | BIOTIS ANAEROBIC KBE AGAR | Otisville Biotech, Inc. | 1984-11-27 | 28 | 0 |
| K834422 | PHENYLETHYL ALCOHOL AGAR PLATE | Otisville Biotech, Inc. | 1984-10-23 | 313 | 0 |
| K834423 | S S AGAR PLATE | Otisville Biotech, Inc. | 1984-10-23 | 313 | 0 |
| K834420 | MANNITOL-SALT AGAR USP PLATE | Otisville Biotech, Inc. | 1984-10-23 | 313 | 0 |
| K834424 | SFP AGAR PLATES | Otisville Biotech, Inc. | 1984-10-23 | 313 | 0 |
| K834419 | COLUMBIA CNA AGAR PLATE | Otisville Biotech, Inc. | 1984-10-23 | 313 | 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