Colbar Lifescience , Ltd.: FDA clearances and approvals
Colbar Lifescience , Ltd. has 1 FDA 510(k) clearance (first 2006, latest 2006), plus 1 PMA decision, across 2 product codes in 2 review panels. Median 510(k) review time: 92 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 |
|---|---|---|---|
| LMH | Implant, Dermal, For Aesthetic Use | 1 | 0 |
| NPL | Barrier, Animal Source, Intraoral | 1 | 1 |
Review panels
Most recent Colbar Lifescience , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K053260 | OSSIX -PLUS | NPL | 2006-02-22 | 92 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P070013 | PMA | EVOLENCE COLLAGEN FILLER | 2008-06-27 |
Recalls
openFDA lists no recalls under a recalling firm named Colbar Lifescience , Ltd..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Colbar Lifescience , Ltd.'s product codes (a text match, not an official crosswalk):
- L8616 — Microphone for use with cochlear implant device, replacement (via LMH)
- L8615 — Headset/headpiece for use with cochlear implant device, replacement (via LMH)
- L8617 — Transmitting coil for use with cochlear implant device, replacement (via LMH)
Frequently asked questions
How many FDA 510(k) clearances does Colbar Lifescience , Ltd. have?
Colbar Lifescience , Ltd. has 1 FDA 510(k) clearance (first 2006, latest 2006), plus 1 PMA decision, across 2 product codes in 2 review panels.
How long does FDA take to clear Colbar Lifescience , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Colbar Lifescience , Ltd.'s cleared 510(k)s is 92 days.
What devices does Colbar Lifescience , Ltd. make?
Its most frequent FDA product codes are LMH (Implant, Dermal, For Aesthetic Use, 1); NPL (Barrier, Animal Source, Intraoral, 1).
Has Colbar Lifescience , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Colbar Lifescience , Ltd. Related entities may recall under other names.
Next steps
- See all 1 Colbar Lifescience , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LMH, Colbar Lifescience , Ltd.'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.