Company ยท US
Salter Labs
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2026. Name variants (Inc, Corp, punctuation) are merged.
50510(k) clearances (1 in 12 months)
7recalls (0 in 12 months)
5recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 11 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 11 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 5 |
| NFB | Conserver, Oxygen | 4 |
| BYG | Mask, Oxygen | 3 |
| BZD | Ventilator, Non-Continuous (Respirator) | 3 |
| CAT | Cannula, Nasal, Oxygen | 3 |
| CCN | Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge | 2 |
| CCQ | Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | 2 |
| MNR | Ventilatory Effort Recorder | 2 |
| BBT | 1 | |
| BTR | Tube, Tracheal (W/Wo Connector) | 1 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 |
| BYF | Mask, Oxygen, Low Concentration, Venturi | 1 |
| BYI | Percussor, Powered-Electric | 1 |
| BZA | Connector, Airway (Extension) | 1 |
| BZG | Spirometer, Diagnostic | 1 |
| BZQ | Monitor, Breathing Frequency | 1 |
| CAN | Regulator, Pressure, Gas Cylinder | 1 |
| CBH | Device, Fixation, Tracheal Tube | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 30, 2026 | K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) Salter Labs | CCL |
| Jan 10, 2020 | K190878 | Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endot Salter Labs, Inc. | BTR |
| Sep 21, 2017 | K161719 | Salter Labs Bubble Humidifier Salter Labs | BTT |
| Apr 15, 2016 | K151874 | BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Salter Labs | MNR |
| Mar 11, 2016 | K151506 | Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula Salter Labs | NFB |
| Mar 10, 2016 | K151421 | Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines Salter Labs | CCK |
| Aug 5, 2015 | K143700 | CPAP Cannulaide Salter Labs | BZD |
| Jun 12, 2015 | K142416 | Luma Wrap Salter Labs | PDH |
| Nov 24, 2009 | K092685 | PNEUMOTHERML, MODEL: 5800 Salter Labs | BZQ |
| Sep 15, 2005 | K051313 | BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER Salter Labs | MNR |
| Mar 4, 2005 | K040202 | SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM Salter Labs | BZD |
| Feb 1, 2002 | K014056 | SALTER LABS MODIFIED NEBUTECH NEBULIZER Salter Labs | CAF |
| Jan 7, 2000 | K992285 | SALTER AIRE COMPRESSOR Salter Labs | CAF |
| Sep 24, 1999 | K992986 | SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER Salter Labs | CAF |
| Aug 6, 1999 | K991788 | SALTER LABS PEP DEVICE Salter Labs | CAF |
| May 7, 1999 | K990678 | PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC) Salter Labs | NFB |
| Dec 17, 1998 | K983403 | SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER Salter Labs | CAF |
| Oct 22, 1996 | K962879 | SALTERLABS 8660 SERIES NEBULIZER Salter Labs | CAF |
| Aug 26, 1996 | K962085 | SALTER LABS 8990 SERIES NEBULIZER Salter Labs | CAF |
| Jul 16, 1996 | K961476 | SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984) Salter Labs | CAF |
| Jul 30, 1991 | K912434 | SALTER LABS INFANT NASAL CPAP CANNULA Salter Labs | BZD |
| Jul 24, 1991 | K912174 | SALTER LABS DISPOSABLE NIPPLE AND NUT Salter Labs | CAN |
| Jul 24, 1991 | K911740 | SALTER LABS NEONATAL NASAL OXYGEN CANNULA Salter Labs | CAT |
| Jul 19, 1991 | K912633 | SALTER LABS INFANT MEDIUM CONCENTRATION MASK Salter Labs | BYG |
| Dec 17, 1990 | K903539 | SALTER LABS MODEL #1015 Salter Labs | CBH |
| Oct 3, 1989 | K894350 | SALTER LABS MODEL #4009 SAMPLE LINES Salter Labs | CCK |
| Jul 24, 1989 | K892407 | MODIFIED DEMAND NASAL OXYGEN CANNULA Salter Labs | NFB |
| Jul 24, 1989 | K892406 | MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA Salter Labs | CCK |
| Feb 23, 1989 | K890298 | DEMAND NASAL OXYGEN CANNULA MODELS 4008/4108/4208 Salter Labs | NFB |
| Feb 17, 1989 | K884947 | HAND HELD NEBULIZER SYSTEM Salter Labs | CAF |
| Aug 19, 1988 | K881663 | OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES Salter Labs | CCL |
| Jun 16, 1988 | K881473 | SL01 OXYGEN ANALYZER Salter Labs | CCL |
| Jun 16, 1988 | K881472 | SL02 OXYGEN ANALYZER Salter Labs | CCL |
| Mar 16, 1987 | K870755 | CHALLENGER DOSIMETER Salter Labs | CCQ |
| Mar 16, 1987 | K870027 | HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER Salter Labs | CCQ |
| Feb 10, 1987 | K865047 | SALTER LABS #4004/4104 OXYGEN MASK W/C02 SAMP LINE Salter Labs | BYG |
| Feb 10, 1987 | K864199 | SALTER LABS #4001 ORAL NASAL CO2 SAMPLING CANNULA Salter Labs | CCK |
| Jan 30, 1987 | K864903 | MOD. 4006 ADU., OXY. DELIVE.-ORAL CO2 SAM. CANNULA Salter Labs | CCK |
| Jan 28, 1987 | K864902 | MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU. Salter Labs | CCK |
| Jan 15, 1987 | K865046 | SALTER LABS MODEL #4005 GAS SAMPLING TEE AND LINE Salter Labs | BZA |
| Oct 27, 1986 | K863883 | MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULA Salter Labs | CCK |
| Oct 15, 1986 | K863703 | SALTER LABS MODEL 4000 NASAL CO2 SAMPLE LINE Salter Labs | CCK |
| Oct 15, 1986 | K863659 | FLOW INTERRUPTION INDICATOR Salter Labs | CCN |
| Oct 15, 1986 | K863657 | OXYGEN CONSERVATOR Salter Labs | CCN |
| Oct 6, 1986 | K863658 | SALTER LABS 3000 SERIES PERCUSSORS Salter Labs | BYI |
| Oct 6, 1986 | K863656 | SALTER VOLUCHEK 6600 Salter Labs | BZG |
| Sep 18, 1986 | K863432 | OXYGEN CANNULA EAR WRAP (STYLE B) Salter Labs | CAT |
| Sep 18, 1986 | K863431 | OXYGEN CANNULA EAR WRAP (STYLE A) Salter Labs | CAT |
| Feb 17, 1984 | K840361 | OXYGEN ANALYZER 200 Salter Labs | CCL |
| Jan 3, 1978 | K772127 | OXYGEN MASK, AIR-ENTRAINMENT Salter Labs | BYF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 10, 2016 | Salter Labs T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment. Terminated |
CAF | K884947 |
| Sep 17, 2015 | Salter Labs NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebulizer used to generate aerosols delivered directly to the patient for breathing. Designed to be used in either a hospital or Terminated |
CAF | K961476 K962879 |
| Jul 23, 2014 | Salter Labs Oxygen Mask, Model No. 8120-7
Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use. Terminated |
BYG | None listed |
| Nov 19, 2013 | SALTER LABS Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors.
Rx only; Made in Mexico; Manufacturer:Salter Labs, 100 West Sycamore Road,
Arvin, CA 93203.
CO2 sample line. Terminated |
CCK | K894350 |
| Jun 27, 2012 | SALTER LABS Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector.
7 ft, oxygen tube, 7 ft. CO2 tube
RX only.For Single Patient Use only.
Distributed by Tri-Anium
Assembled in Mexico.
Usage: De Terminated |
CCK | K892406 |
| Jan 26, 2012 | SALTER LABS Salter Labs Bubble humidifier, with 6 PSI safety valve, 350cc, Latex Free; Single Patient use; used with supplemental oxygen therapy. Model Numbers 7600-0-50, E7600-0-50, NP7600-0-50 and special ord Terminated |
BBT | None listed |
| Jan 11, 2012 | SALTER LABS ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery, Model number 4707 7-7-24.
Salter Labs Nasal Cannula (Adult), Salter Style
with modified nasal prongs.
w/7' O2 line and 7' CO2 line wi Terminated |
CCK | K892406 |