Sierra Laboratories, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Sierra Laboratories, Inc.” (first 1979, latest 1997), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 52 days. 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 | 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 |
|---|---|---|---|
| EXJ | Device, Incontinence, Urosheath Type, Sterile | 5 | 5 |
| BYN | Chair, Posture, For Cardiac And Pulmonary Treatment | 1 | 1 |
| EFD | Amalgamator, Dental, Ac-Powered | 1 | 1 |
| EYT | Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile | 1 | 1 |
| EYZ | System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | 1 | 1 |
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | 1 | 1 |
| KBC | Saw, Nasal | 1 | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 | 1 |
Review panels
Most recent Sierra Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970966 | COMFORT CATH CHOICE MALE EXTERNAL CATHETER | EXJ | 1997-04-22 | 36 |
| K962413 | COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER | EXJ | 1996-07-15 | 24 |
| K962384 | COMFORT SHEATH REUSABLE MALE EXTERNAL CATHETER | EXJ | 1996-07-15 | 25 |
| K934266 | COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER | EXJ | 1994-04-19 | 231 |
| K934052 | ALPINE REUSABLE LEG BAGS | FAQ | 1994-01-07 | 141 |
| K931156 | CONE CATH | EXJ | 1993-07-01 | 114 |
| K901000 | URO TEX URINALS | EYZ | 1990-03-26 | 24 |
| K883057 | COMFORT CATH MALE EXTERNAL CATHETER | EYT | 1988-08-02 | 14 |
| K873039 | MODEL 820 TOP=TRAK | BYN | 1988-02-11 | 191 |
| K832450 | URO-TEX MALE EXTERNAL CATHETER | KNX | 1983-10-14 | 80 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Sierra Laboratories, Inc..
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.
- Sierra Medical Devices (2 510(k)s)
- Sierra Scientific Instruments, Inc. (2 510(k)s)
- Sierra Corp. (1 510(k)s)
- Sierra Battery, Inc. (1 510(k)s)
- Sierra Biosearch, Inc. (1 510(k)s)
- Sierra Diagnostic, LLC (1 510(k)s)
- Sierra Diagnostics (1 510(k)s)
- Sierra Surgical, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sierra Laboratories, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Sierra Laboratories, Inc.” (first 1979, latest 1997), across 8 product codes in 4 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 Sierra Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sierra Laboratories, Inc. is 52 days.
Which FDA product codes appear under Sierra Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are EXJ (Device, Incontinence, Urosheath Type, Sterile, 5); BYN (Chair, Posture, For Cardiac And Pulmonary Treatment, 1); EFD (Amalgamator, Dental, Ac-Powered, 1).
Next steps
- See all 12 Sierra Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EXJ, Sierra Laboratories, Inc.'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.