Blue Sky Bio, LLC: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Blue Sky Bio, LLC” (first 2000, latest 2024), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 149 days. Since 2017 the median was 165 days, against 150 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 119 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 190 |
| 2017 | 1 | 259 |
| 2018 | 2 | 48 |
| 2019 | 1 | 165 |
| 2020 | 2 | 154 |
| 2021 | 0 | — |
| 2022 | 1 | 302 |
| 2023 | 1 | 245 |
| 2024 | 1 | 216 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Blue Sky Bio, LLC took a median 165 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 150 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 10 | 10 |
| NXC | Aligner, Sequential | 3 | 3 |
| LYC | Bone Grafting Material, Synthetic | 2 | 2 |
| NHA | Abutment, Implant, Dental, Endosseous | 2 | 2 |
| DYW | Bracket, Plastic, Orthodontic | 1 | 1 |
| EIH | Powder, Porcelain | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
| OAT | Implant, Endosseous, Orthodontic | 1 | 1 |
Review panels
Most recent Blue Sky Bio, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232653 | Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX | NXC | 2024-04-03 | 216 |
| K221845 | Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G | NXC | 2023-02-24 | 245 |
| K212785 | Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments | DZE | 2022-06-30 | 302 |
| K202026 | Blue Sky Bio CAD-CAM Abutments | NHA | 2020-12-18 | 149 |
| K201919 | Blue Sky Bio TAD | OAT | 2020-12-17 | 160 |
| K190491 | Blue Sky Bio Zygomatic Implant System | NHA | 2019-08-12 | 165 |
| K182338 | Blue Sky Bio Computerized Orthodontic Bracket System | DYW | 2018-11-09 | 73 |
| K180107 | Blue Sky Bio Aligner | NXC | 2018-02-09 | 24 |
| K163251 | Life Essence Universal Porcelain System | EIH | 2017-08-04 | 259 |
| K153064 | Blue Sky Bio Zygomatic Implant System | DZE | 2016-04-29 | 190 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Blue Sky Bio, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Blue Belt Technologies, Inc. (22 510(k)s)
- Blue Ridge Media Co. (11 510(k)s)
- Blue Ortho (9 510(k)s)
- Blue Sky Medical Group Incorporated (4 510(k)s)
- Blue Planet Industries, Inc. (3 510(k)s)
- Blue Sail Medical Co.,Ltd (2 510(k)s)
- Blue Spark Technologies, Inc. (2 510(k)s)
- Blue Torch Medical Technologies (2 510(k)s)
- Blue X Imaging Srl (2 510(k)s)
- Blue Cross Bio-Medical Co., Ltd. (1 510(k)s)
- Blue Dent Dental (1 510(k)s)
- Blue Egg CO (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Blue Sky Bio, LLC?
FDA lists 21 510(k) clearances under the applicant name “Blue Sky Bio, LLC” (first 2000, latest 2024), across 8 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Blue Sky Bio, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Blue Sky Bio, LLC is 149 days. Since 2017: 165 days, versus 150 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Blue Sky Bio, LLC?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 10); NXC (Aligner, Sequential, 3); LYC (Bone Grafting Material, Synthetic, 2).
Next steps
- See all 21 Blue Sky Bio, LLC clearances with predicates and recalls
- Run predicate analysis for product code DZE, Blue Sky Bio, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.