Palco Laboratories, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Palco Laboratories, Inc.” (first 1983, latest 1995), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 120 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 |
|---|---|---|---|
| DQA | Oximeter | 4 | 4 |
| FMF | Syringe, Piston | 1 | 1 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 1 | 1 |
| KPN | Alarm, Conditioned Response Enuresis | 1 | 1 |
| KZH | Introducer, Syringe Needle | 1 | 1 |
| LDQ | 1 | 1 |
Review panels
- Anesthesiology (4)
- General Hospital (2)
- Gastroenterology and Urology (1)
- General and Plastic Surgery (1)
Most recent Palco Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942810 | PALCO LABS COLD POUCH | LDQ | 1995-06-28 | 378 |
| K943842 | PULSE OXIMETER MODEL 305 | DQA | 1995-03-24 | 231 |
| K920066 | PALCO LABS MODEL 340 PULSE OXIMETER | DQA | 1993-03-16 | 434 |
| K913694 | PALCO LABS LOADMATIC | FMF | 1991-12-17 | 120 |
| K911191 | PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR | DQA | 1991-06-10 | 84 |
| K904988 | PALCO LABS MODEL 400 OXYGEN/PULSE MONITOR | DQA | 1991-03-18 | 131 |
| K872233 | INJECT-EASE | KZH | 1987-09-04 | 86 |
| K842547 | WET-STOP | KPN | 1984-10-19 | 109 |
| K833344 | AUTO-LANCET | FMK | 1983-11-07 | 41 |
Recalls
openFDA lists no recalls under a recalling firm named Palco 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.
- Palco Labs, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Palco Laboratories, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Palco Laboratories, Inc.” (first 1983, latest 1995), across 6 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 Palco Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Palco Laboratories, Inc. is 120 days.
Which FDA product codes appear under Palco Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are DQA (Oximeter, 4); FMF (Syringe, Piston, 1); FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, 1).
Next steps
- See all 9 Palco Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQA, Palco 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.