Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biological & Environmental Control Laboratories — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
41 daysmedian FDA review time
127 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971500 | ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER | Biological & Environmental Control Laboratories | 1997-08-18 | 116 | 0 |
| K962802 | SAFE MATE I.V. FLUID DELIVERY SETS | Biological & Environmental Control Laboratories | 1996-08-28 | 41 | 0 |
| K962801 | SAFE MATE I.V. EXTENSION SETS | Biological & Environmental Control Laboratories | 1996-08-28 | 41 | 0 |
| K961328 | BEC SHROUDED PLASTIC CANNULA | Biological & Environmental Control Laboratories | 1996-05-30 | 52 | 0 |
| K961327 | BEC NEEDLELESS INJECTION SITE | Biological & Environmental Control Laboratories | 1996-05-15 | 37 | 0 |
| K863635 | UPDATED STERILE ENDOTRACHEAL BRUSHES | Biological & Environmental Control Laboratories | 1986-11-03 | 47 | 0 |
| K863633 | SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES | Biological & Environmental Control Laboratories | 1986-10-16 | 29 | 0 |
| K863636 | UPDATED STERILE GENERAL HOSPITAL INSTRUMENTS | Biological & Environmental Control Laboratories | 1986-10-06 | 19 | 0 |
| K863632 | UPDATED STERILE PROCEDURAL KIT | Biological & Environmental Control Laboratories | 1986-09-29 | 12 | 0 |
| K863637 | UPDATED STERILE GOWNS, MASKS AND TOWELS | Biological & Environmental Control Laboratories | 1986-09-29 | 12 | 0 |
| K851851 | STERILE ENDOTRACHEAL BRUSHES | Biological & Environmental Control Laboratories | 1985-06-05 | 40 | 0 |
| K851390 | STERILE GENERAL HOSPITAL SUPPLIES | Biological & Environmental Control Laboratories | 1985-05-29 | 50 | 0 |
| K851852 | GENERAL HOSPITAL INSTRUMENTS | Biological & Environmental Control Laboratories | 1985-05-21 | 25 | 0 |
| K851853 | STERILE GOWNS, MASKS & TOWELS | Biological & Environmental Control Laboratories | 1985-05-16 | 20 | 0 |
| K842990 | STERILE EYE SURGERY KITS | Biological & Environmental Control Laboratories | 1985-05-09 | 283 | 0 |
| K844196 | WET SKIN SCRUB TRAY STERILE WET SKIN SCRUB KIT | Biological & Environmental Control Laboratories | 1984-12-04 | 35 | 0 |
| K842989 | SHAVE PREP KITS | Biological & Environmental Control Laboratories | 1984-12-04 | 127 | 0 |
| K842490 | SKIN SCRUB TRAY STERILE SKIN SCRUB KIT | Biological & Environmental Control Laboratories | 1984-08-17 | 52 | 0 |
| K842579 | B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONS | Biological & Environmental Control Laboratories | 1984-07-27 | 24 | 1 |
| K821769 | MICROKNIFE | Biological & Environmental Control Laboratories | 1982-09-14 | 96 | 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