Life Sciences Manufacturing, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Life Sciences Manufacturing, Inc.” (first 1979, latest 1991), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 144 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 |
|---|---|---|---|
| DSB | Plethysmograph, Impedance | 3 | 3 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 3 | 3 |
| DQC | Phonocardiograph | 2 | 2 |
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | 2 | 2 |
| DPT | Probe, Blood-Flow, Extravascular | 1 | 1 |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | 1 | 1 |
Review panels
- Cardiovascular (12)
Most recent Life Sciences Manufacturing, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K910905 | SFA-II MICROPROCESSOR-CONTROLLED MODULE | DRQ | 1991-07-24 | 141 |
| K903700 | IPG-II MODULE | DSB | 1991-01-16 | 154 |
| K900365 | PAG MICROPROCESSOR-CONTROLLED MODULE | DQC | 1990-07-18 | 174 |
| K896500 | CWD/PPG MODULE | JOM | 1990-07-18 | 246 |
| K895588 | PORTABLE AIR PLETHYSMOGRAPH | DSB | 1990-03-27 | 193 |
| K896528 | SFA MODULE | DXG | 1990-01-26 | 71 |
| K884624 | MVL/MODULAB WITH PVR MODULE | JOM | 1989-02-01 | 89 |
| K873041 | A-V RECORDER | DPT | 1988-02-04 | 184 |
| K832679 | NON-INVASIVE CLINICAL VASCULAR LAB | DQC | 1984-01-03 | 147 |
| K822522 | CUTANEOUS PRESSURE PLETHYSMOGRAPH | DSB | 1982-09-28 | 36 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Life Sciences Manufacturing, 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.
- Life Spine, Inc. (123 510(k)s)
- Life Design Systems, Inc. (29 510(k)s)
- Life Science Instrumentation, Inc. (20 510(k)s)
- Life Support Products, Inc. (20 510(k)s)
- Life Shield Healthcare Products, Inc. (17 510(k)s)
- Life Technologies Corporation (10 510(k)s)
- Life Products, Inc. (10 510(k)s)
- Life Corp. (5 510(k)s)
- Life Sensing Instrument Company, Inc. (5 510(k)s)
- Life Enhancement Technologies, LLC (3 510(k)s)
- Life Global Group, LLC (3 510(k)s)
- Life Medical Sciences, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Life Sciences Manufacturing, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Life Sciences Manufacturing, Inc.” (first 1979, latest 1991), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Life Sciences Manufacturing, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Life Sciences Manufacturing, Inc. is 144 days.
Which FDA product codes appear under Life Sciences Manufacturing, Inc.?
The most frequent FDA product codes under this applicant name are DSB (Plethysmograph, Impedance, 3); DXG (Computer, Diagnostic, Pre-Programmed, Single-Function, 3); DQC (Phonocardiograph, 2).
Next steps
- See all 12 Life Sciences Manufacturing, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSB, Life Sciences Manufacturing, 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.