Salter Labs
Salter Labs holds FDA 510(k) medical device clearances, first cleared 1978, most recent 2026, with 5 FDA device recalls on record.
Top product codes for Salter Labs
FDA recalls by Salter Labs
- Z-0796-2016 — 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.
- Z-2781-2015 — 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 homecare environment.
- Z-2093-2014 — 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.
- Z-0360-2014 — 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.
- Z-1898-2012 — 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: Delivery of Anesthesia.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Salter Labs
- K261389 — PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)
- K161719 — Salter Labs Bubble Humidifier
- K151874 — BiNAPS Nasal Airflow and Snore Transducer +1 more
- K151506 — Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula
- K151421 — Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines
- K143700 — CPAP Cannulaide
- K142416 — Luma Wrap
- K092685 — PNEUMOTHERML, MODEL: 5800
- K051313 — BI-NAPS NASAL AIRFLOW AND SNORE TRANSDUCER
- K040202 — SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM
- K014056 — SALTER LABS MODIFIED NEBUTECH NEBULIZER
- K992285 — SALTER AIRE COMPRESSOR
- K992986 — SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER
- K991788 — SALTER LABS PEP DEVICE
- K990678 — PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC)
- K983403 — SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER
- K962879 — SALTERLABS 8660 SERIES NEBULIZER
- K962085 — SALTER LABS 8990 SERIES NEBULIZER
- K961476 — SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)
- K912434 — SALTER LABS INFANT NASAL CPAP CANNULA
- K911740 — SALTER LABS NEONATAL NASAL OXYGEN CANNULA
- K912174 — SALTER LABS DISPOSABLE NIPPLE AND NUT
- K912633 — SALTER LABS INFANT MEDIUM CONCENTRATION MASK
- K903539 — SALTER LABS MODEL #1015
- K894350 — SALTER LABS MODEL #4009 SAMPLE LINES
- K892406 — MODIFIED OXYGEN DELIVERY/CO2 SAMPLE NASAL CANNULA
- K892407 — MODIFIED DEMAND NASAL OXYGEN CANNULA
- K890298 — DEMAND NASAL OXYGEN CANNULA MODELS 4008/4108/4208
- K884947 — HAND HELD NEBULIZER SYSTEM
- K881663 — OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES
- K881472 — SL02 OXYGEN ANALYZER
- K881473 — SL01 OXYGEN ANALYZER
- K870027 — HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER
- K870755 — CHALLENGER DOSIMETER
- K864199 — SALTER LABS #4001 ORAL NASAL CO2 SAMPLING CANNULA
- K865047 — SALTER LABS #4004/4104 OXYGEN MASK W/C02 SAMP LINE
- K864903 — MOD. 4006 ADU., OXY. DELIVE.-ORAL CO2 SAM. CANNULA
- K864902 — MOD. 4003 ADU., OXY. DELIVE.-ORAL/NASAL CO2 CANNU.
- K865046 — SALTER LABS MODEL #4005 GAS SAMPLING TEE AND LINE
- K863883 — MODELS 4002/4102/4202 OXY. DELIVERY/CO2 CANNULA
- K863657 — OXYGEN CONSERVATOR
- K863659 — FLOW INTERRUPTION INDICATOR
- K863703 — SALTER LABS MODEL 4000 NASAL CO2 SAMPLE LINE
- K863656 — SALTER VOLUCHEK 6600
- K863658 — SALTER LABS 3000 SERIES PERCUSSORS
- K863431 — OXYGEN CANNULA EAR WRAP (STYLE A)
- K863432 — OXYGEN CANNULA EAR WRAP (STYLE B)
- K840361 — OXYGEN ANALYZER 200
- K772127 — OXYGEN MASK, AIR-ENTRAINMENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.