Biological & Environmental Control Laboratories: FDA clearances and approvals
Biological & Environmental Control Laboratories has 20 FDA 510(k) clearances (first 1982, latest 1997), across 10 product codes in 5 review panels. Median 510(k) review time: 40 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 4 | 4 |
| KME | Bedding, Disposable, Medical | 2 | 2 |
| LDQ | 2 | 2 | |
| EMF | Knife, Surgical | 1 | 1 |
| EPE | Brush, Cleaning, Tracheal Tube | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| HOZ | Sponge, Ophthalmic | 1 | 1 |
| JTR | Kit, Quality Control For Culture Media | 1 | 1 |
Plus 1 more product codes.
Review panels
- General Hospital (8)
- Anesthesiology (1)
- Microbiology (1)
- Ophthalmic (1)
- General and Plastic Surgery (1)
Most recent Biological & Environmental Control Laboratories 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971500 | ACCESS SYSTEMS NEEDLELESS VIAL ADAPTER | FPA | 1997-08-18 | 116 |
| K962802 | SAFE MATE I.V. FLUID DELIVERY SETS | FPA | 1996-08-28 | 41 |
| K962801 | SAFE MATE I.V. EXTENSION SETS | FPA | 1996-08-28 | 41 |
| K961328 | BEC SHROUDED PLASTIC CANNULA | FMI | 1996-05-30 | 52 |
| K961327 | BEC NEEDLELESS INJECTION SITE | FPA | 1996-05-15 | 37 |
| K863635 | UPDATED STERILE ENDOTRACHEAL BRUSHES | EPE | 1986-11-03 | 47 |
| K863633 | SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES | LDQ | 1986-10-16 | 29 |
| K863636 | UPDATED STERILE GENERAL HOSPITAL INSTRUMENTS | — | 1986-10-06 | 19 |
| K863637 | UPDATED STERILE GOWNS, MASKS AND TOWELS | — | 1986-09-29 | 12 |
| K863632 | UPDATED STERILE PROCEDURAL KIT | — | 1986-09-29 | 12 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biological & Environmental Control Laboratories.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Biological & Environmental Control Laboratories have?
Biological & Environmental Control Laboratories has 20 FDA 510(k) clearances (first 1982, latest 1997), across 10 product codes in 5 review panels.
How long does FDA take to clear Biological & Environmental Control Laboratories's 510(k)s?
The median time from FDA receipt to decision across Biological & Environmental Control Laboratories's cleared 510(k)s is 40 days.
What devices does Biological & Environmental Control Laboratories make?
Its most frequent FDA product codes are FPA (Set, Administration, Intravascular, 4); KME (Bedding, Disposable, Medical, 2); LDQ (device, 2).
Has Biological & Environmental Control Laboratories had device recalls?
openFDA lists no recalls under a recalling firm name matching Biological & Environmental Control Laboratories. Related entities may recall under other names.
Next steps
- See all 20 Biological & Environmental Control Laboratories clearances with predicates and recalls
- Run predicate analysis for product code FPA, Biological & Environmental Control Laboratories's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.